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| design history file example: Medical Instrument Design and Development Claudio Becchetti, Alessandro Neri, 2013-05-20 This book explains all of the stages involved in developingmedical devices; from concept to medical approval including systemengineering, bioinstrumentation design, signal processing,electronics, software and ICT with Cloud and e-Healthdevelopment. Medical Instrument Design and Development offers a comprehensivetheoretical background with extensive use of diagrams, graphics andtables (around 400 throughout the book). The book explains how thetheory is translated into industrial medical products using amarket-sold Electrocardiograph disclosed in its design by the GammaCardio Soft manufacturer. The sequence of the chapters reflects the product developmentlifecycle. Each chapter is focused on a specific University courseand is divided into two sections: theory and implementation. Thetheory sections explain the main concepts and principles whichremain valid across technological evolutions of medicalinstrumentation. The Implementation sections show how the theory istranslated into a medical product. The Electrocardiograph(ECG or EKG) is used as an example as it is a suitable device toexplore to fully understand medical instrumentation since it issufficiently simple but encompasses all the main areas involved indeveloping medical electronic equipment. Key Features: Introduces a system-level approach to product design Covers topics such as bioinstrumentation, signal processing,information theory, electronics, software, firmware, telemedicine,e-Health and medical device certification Explains how to use theory to implement a market product (usingECG as an example) Examines the design and applications of main medicalinstruments Details the additional know-how required for productimplementation: business context, system design, projectmanagement, intellectual property rights, product life cycle,etc. Includes an accompanying website with the design of thecertified ECG product (ahref=http://www.gammacardiosoft.it/bookwww.gammacardiosoft.it/book/a) Discloses the details of a marketed ECG Product (from GammaCardio Soft) compliant with the ANSI standard AAMI EC 11under open licenses (GNU GPL, Creative Common) This book is written for biomedical engineering courses(upper-level undergraduate and graduate students) and for engineersinterested in medical instrumentation/device design with acomprehensive and interdisciplinary system perspective. |
| design history file example: Design of Biomedical Devices and Systems Second edition Paul H. King, Richard C. Fries, 2008-08-22 The design and functional complexity of medical devices and systems has increased during the past half century, evolving from the level of cardiac pacemakers to magnetic resonance imaging devices. Such life-saving advancements are monumentally advantageous, but with so much at stake, a step-by-step manual for biomedical engineers is essential. This |
| design history file example: Device Inspections Guide , 2003 |
| design history file example: DESIGN CONTROLS, RISK MANAGEMENT & PROCESS VALIDATION FOR MEDICAL DEVICE PROFESSIONALS Vernon M. Geckler, 2017-02-11 This handbook provides the most up to date resource currently available for interpreting and understanding design controls. This handbook is the most exhaustive resource ever written about FDA & ISO 13485 design controls for medical devices with a collection of all applicable regulations and real-world examples. Four-hundred & forty, 8.5 X 11 pages provides an extensive evaluation of FDA 21 CFR 820 and is cross-referenced with ISO 13485 to provide readers with a broad and in-depth review of practical design control implementation techniques. This handbook also covers basic, intermediate and advanced design control topics and is an ideal resource for implementing new design control processes or upgrading an existing process into medical device quality systems. This critical resource also specifically outlines key topics which will allow quality managers and medical device developers to improve compliance quickly to pass internal and external audits and FDA inspections. The author breaks down the regulation line by line and provides a detailed interpretation by using supportive evidence from the FDA design control guidance and the quality systems preamble. Numerous examples, case studies, best practices, 70+ figures and 45+ tables provide practical implementation techniques which are based on the author's extensive experience launching numerous medical device products and by integrating industry consultant expertise. In addition, bonus chapters include: explanation of medical device classification, compliance to design controls, risk management, and the design control quality system preamble. 20-40 pages are dedicated to each of the major design control topics: Design and Development Planning, Design Input, Design Output, Design Transfer, Design Verification, Design Validation, Design Change and Design History File. |
| design history file example: ISO 9001:2000 Quality Management System Design Jay J. Schlickman, 2003 The book describes the design rules required to document, implement, and demonstrate quality management system effectiveness in compliance with the latest version of the ISO 9000 International Standard. This systematic and engineering approach simplifies the many complexities in maintaining compliance with ISO standards. This hands-on guide is packed with tips and insights the author has garnered from personally designing quality management systems that integrate organizational strategy with quality management. Moreover, the book helps professionals create meaningful documentation and a user-friendly, informative quality manual that together form the core of an effective and responsive quality management system.--Jacket. |
| design history file example: Biomedical Engineering Design Joseph Tranquillo, Jay Goldberg, Robert Allen, 2022-02-19 Biomedical Engineering Design presents the design processes and practices used in academic and industry medical device design projects. The first two chapters are an overview of the design process, project management and working on technical teams. Further chapters follow the general order of a design sequence in biomedical engineering, from problem identification to validation and verification testing. The first seven chapters, or parts of them, can be used for first-year and sophomore design classes. The next six chapters are primarily for upper-level students and include in-depth discussions of detailed design, testing, standards, regulatory requirements and ethics. The last two chapters summarize the various activities that industry engineers might be involved in to commercialize a medical device. - Covers subject matter rarely addressed in other BME design texts, such as packaging design, testing in living systems and sterilization methods - Provides instructive examples of how technical, marketing, regulatory, legal, and ethical requirements inform the design process - Includes numerous examples from both industry and academic design projects that highlight different ways to navigate the stages of design as well as document and communicate design decisions - Provides comprehensive coverage of the design process, including methods for identifying unmet needs, applying Design for 'X', and incorporating standards and design controls - Discusses topics that prepare students for careers in medical device design or other related medical fields |
| design history file example: Design Controls for the Medical Device Industry, Second Edition Marie B. Teixeira, 2013-11-12 The second edition of a bestseller, Design Controls for the Medical Device Industry provides a comprehensive review of the latest design control requirements, as well as proven tools and techniques to ensure your company’s design control program evolves in accordance with current industry practice. The text assists in the development of an effective design control program that not only satisfies the US FDA Quality System Regulation (QSR) and ISO 9001 and 13485 standards, but also meets today’s third-party auditor/investigator expectations and saves you valuable time and money. The author’s continual participation in FDA QSR inspections and Notified Body ISO audits is reflected in updates to all chapters and appendices of the book, now bursting at the seams with: New coverage of ISO 9001 and 13485 design control requirements More real-world examples from the medical device industry Additional detail for greater understanding and clarity Fresh templates for practical implementation Extensive references for further study The book addresses design control elements such as design planning, input, output, review, verification, validation, change, transfer, and history, as well as risk management inclusive of human factors and usability, biocompatibility, the FDA Quality System Inspection Technique (QSIT) for design controls, and medical device regulations and classes in the US, Canada, and Europe. |
| design history file example: Design of Biomedical Devices and Systems, Third Edition Paul H. King, Richard C. Fries, Arthur T. Johnson, 2014-07-29 Apply a Wide Variety of Design Processes to a Wide Category of Design Problems Design of Biomedical Devices and Systems, Third Edition continues to provide a real-world approach to the design of biomedical engineering devices and/or systems. Bringing together information on the design and initiation of design projects from several sources, this edition strongly emphasizes and further clarifies the standards of design procedure. Following the best practices for conducting and completing a design project, it outlines the various steps in the design process in a basic, flexible, and logical order. What’s New in the Third Edition: This latest edition contains a new chapter on biological engineering design, a new chapter on the FDA regulations for items other than devices such as drugs, new end-of-chapter problems, new case studies, and a chapter on product development. It adds mathematical modeling tools, and provides new information on FDA regulations and standards, as well as clinical trials and sterilization methods. Familiarizes the reader with medical devices, and their design, regulation, and use Considers safety aspects of the devices Contains an enhanced pedagogy Provides an overview of basic design issues Design of Biomedical Devices and Systems, Third Edition covers the design of biomedical engineering devices and/or systems, and is designed to support bioengineering and biomedical engineering students and novice engineers entering the medical device market. |
| design history file example: The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices Amiram Daniel, Ed Kimmelman, 2008-02-21 This new and expanded second edition maintains the organizational approach of the first and includes the requirements and guidance contained in the Quality System Regulation (QSReg), the ISO 13485:2003 standard, the ISO/TR 14969:2004 guidance document, and, as appropriate, a number of the FDA and Global Harmonization Task Force (GHTF) guidance documents.This second edition also addresses a number of additional topics, such as the incorporation of risk management into the medical device organization’s QMS, QMS issues related to combination products, the key process interactions within a QMS, effective presentation of and advocacy for a QMS during FDA inspections and third-party assessments, and future FDA compliance and standards activities. The organization of the guidebook is based on the order of the requirements in the QSReg. For each substantive requirement section there is: A verbatim statement of the QSReg requirement. A description of the comparable requirement in ISO 13485:2003, focusing on any additions to or differences from the requirements contained in the QSReg.Excerpts of the FDA responses to relevant comment groups contained in the Preamble to the QSReg. Excerpts from various FDA guidance documents related to quality management systems. A description of the relevant guidance contained in ISO/TR 14969:2004, focusing on any additions to or differences from the guidance in the Preamble and other FDA guidance documents, and, if useful, excerpts from relevant GHTF guidances. Authors’ notes giving guidance derived from the authors’ sixty years of regulatory compliance experience. This guidance book is meant as a resource to manufacturers of medical devices, providing up-to-date information concerning required and recommended quality system practices. It should be used as a companion to the regulations/standards themselves and texts on the specific processes and activities contained within the QMS. |
| design history file example: Introduction to Product Design and Development for Engineers Dr. Ali Jamnia, 2018-06-01 Introduction to Product Design and Development for Engineers provides guidelines and best practices for the design, development, and evaluation of engineered products. Created to serve fourth year undergraduate students in Engineering Design modules with a required project, the text covers the entire product design process and product life-cycle, from the initial concept to the design and development stages, and through to product testing, design documentation, manufacturability, marketing, and sustainability. Reflecting the author's long career as a design engineer, this text will also serve as a practical guide for students working on their capstone design projects. |
| design history file example: Documenting the Software Development Process Steve J. Ayer, Frank S. Patrinostro, 1992 A structured approach to systems development that views the creation of documentation as a combined effort of systems planners, analysts, programmers, and technical writers. Includes alternatives for each of the documents presented and a chapter on integrating a systems development methodology with CASE. Annotation copyrighted by Book News, Inc., Portland, OR |
| design history file example: Medical Device Design and Regulation Carl T. DeMarco, 2011-01-01 |
| design history file example: ISO 13485:2016 Itay Abuhav, 2018-05-11 Summary: This book provides valuable, effective guidance for understanding, interpreting and implementing ISO 13485:2016 standard requirements. Despite its more than 800-page length, the author has specifically designed its contents to maximize usability for the reader with a table of contents identical to that of the ISO standard itself, which enables easy navigation and orientation. Pragmatic in style and down to earth in tone, this book draws real-life examples and case-studies from the author’s many years of experience in consulting to illustrate even the most complex of ISO 13485:2016 standard requirements and their implementation. Identifying relevant requirements and how they harmonize with quality management systems, developing processes for design and development, as well as product realization and validation are just a few of the issues covered in-depth by this publication. In addition, the author constantly reviews the distinctive characteristics and aspects of the medical device manufacturing industry, so that the reader can also appreciate the subject of this book in an everyday context. Features: A pragmatic and down to earth approach towards the reader’s understanding of ISO 13485:2016 standard requirements implementation. Uses examples and cases from real-life based on the author’s many years of experience in quality management. A table of contents structured identically to that of ISO 13485:2016 itself, allowing easier navigation and orientation for the reader. Emphasises guidance for ISO 13495:2016 standard requirements which are difficult to interpret and implement Constantly reviews the aspect of medical device industry characteristics and distinctive so the reader can reflect the content with its daily work. |
| design history file example: Executing Design for Reliability Within the Product Life Cycle Ali Jamnia, Khaled Atua, 2019-11-13 At an early stage of the development, the design teams should ask questions such as, How reliable will my product be? How reliable should my product be? And, How frequently does the product need to be repaired / maintained? To answer these questions, the design team needs to develop an understanding of how and why their products fails; then, make only those changes to improve reliability while remaining within cost budget. The body of available literature may be separated into three distinct categories: theory of reliability and its associated calculations; reliability analysis of test or field data – provided the data is well behaved; and, finally, establishing and managing organizational reliability activities. The problem remains that when design engineers face the question of design for reliability, they are often at a loss. What is missing in the reliability literature is a set of practical steps without the need to turn to heavy statistics. Executing Design for Reliability Within the Product Life Cycle provides a basic approach to conducting reliability-related streamlined engineering activities, balancing analysis with a high-level view of reliability within product design and development. This approach empowers design engineers with a practical understanding of reliability and its role in the design process, and helps design team members assigned to reliability roles and responsibilities to understand how to deploy and utilize reliability tools. The authors draw on their experience to show how these tools and processes are integrated within the design and development cycle to assure reliability, and also to verify and demonstrate this reliability to colleagues and customers. |
| design history file example: Introduction to Medical Software Xenophon Papademetris, Ayesha N. Quraishi, Gregory P. Licholai, 2022-05-05 A concise and accessible overview of the design, implementation and management of medical software. |
| design history file example: Medical Device Quality Assurance and Regulatory Compliance Richard C. Fries, 1998-08-11 Acquaints developers of medical devices with the basic concepts and major issues of medical quality assurance and regulatory documents, describes the requirements listed in these documents, and provides strategies for compliance with these requirements. |
| design history file example: Mission-Critical and Safety-Critical Systems Handbook Kim Fowler, 2009-11-19 This handbook provides a consolidated, comprehensive information resource for engineers working with mission and safety critical systems. Principles, regulations, and processes common to all critical design projects are introduced in the opening chapters. Expert contributors then offer development models, process templates, and documentation guidelines from their own core critical applications fields: medical, aerospace, and military. Readers will gain in-depth knowledge of how to avoid common pitfalls and meet even the strictest certification standards. Particular emphasis is placed on best practices, design tradeoffs, and testing procedures. - Comprehensive coverage of all key concerns for designers of critical systems including standards compliance, verification and validation, and design tradeoffs - Real-world case studies contained within these pages provide insight from experience |
| design history file example: Design of Biomedical Devices and Systems, 4th edition Paul H. King, Richard C. Fries, Arthur T. Johnson, 2018-10-03 This fourth edition is a substantial revision of a highly regarded text, intended for senior design capstone courses within departments of biomedical engineering, bioengineering, biological engineering and medical engineering, worldwide. Each chapter has been thoroughly updated and revised to reflect the latest developments. New material has been added on entrepreneurship, bioengineering design, clinical trials and CRISPR. Based upon feedback from prior users and reviews, additional and new examples and applications, such as 3D printing have been added to the text. Additional clinical applications were added to enhance the overall relevance of the material presented. Relevant FDA regulations and how they impact the designer’s work have been updated. Features Provides updated material as needed to each chapter Incorporates new examples and applications within each chapter Discusses new material related to entrepreneurship, clinical trials and CRISPR Relates critical new information pertaining to FDA regulations. Presents new material on discovery of projects worth pursuing and design for health care for low-resource environments Presents multiple case examples of entrepreneurship in this field Addresses multiple safety and ethical concerns for the design of medical devices and processes |
| design history file example: Medical Device Design , 2012-12-17 This book provides the bridge between engineering design and medical device development. There is no single text that addresses the plethora of design issues a medical devices designer meets when developing new products or improving older ones. It addresses medical devices' regulatory (FDA and EU) requirements--some of the most stringent engineering requirements globally. Engineers failing to meet these requirements can cause serious harm to users as well as their products’ commercial prospects. This Handbook shows the essential methodologies medical designers must understand to ensure their products meet requirements. It brings together proven design protocols and puts them in an explicit medical context based on the author's years of academia (R&D phase) and industrial (commercialization phase) experience. This design methodology enables engineers and medical device manufacturers to bring new products to the marketplace rapidly. The medical device market is a multi-billion dollar industry. Every engineered product for this sector, from scalpelsstents to complex medical equipment, must be designed and developed to approved procedures and standards. This book shows how Covers US, and EU and ISO standards, enabling a truly international approach, providing a guide to the international standards that practicing engineers require to understand Written by an experienced medical device engineers and entrepreneurs with products in the from the US and UK and with real world experience of developing and commercializing medical products |
| design history file example: FDA Regulatory Affairs Douglas J. Pisano, David S. Mantus, 2008-08-11 Examines harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations as they apply to human drug and device development, research, manufacturing, and marketing. The Second Edition focuses on the new drug approval process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements. Written in |
| design history file example: The Williams Dictionary of Biomaterials , 1999-01-01 There has been a rapid expansion of activity in the area of biomaterials and related medical devices, both in scientific terms and in clinical and commercial applications. The definition of terms has failed to keep pace with the rapidity of these developments and there is considerable confusion over the terminology used in this highly multi- and inter-disciplinary area. This confusion has arisen partly from the use of inappropriate terms which already have well-defined meanings in their parent disciplines, but which are used inexpertly by those working in other disciplines, and partly from the haphazard generation of new terms for the purpose of defining new phenomena or devices. For example, many terms used in pathology with distinct, if not readily understood, meanings are used by materials scientists to describe biocompatibility phenomena with slightly changed or even wholly misrepresented meanings; similarly, terms from materials science and engineering are seriously misused by biologists and clinicians working in this field. The leading proponent of harmonization and clarity in medical device terminology, Professor D. F. Williams has been influential in setting the standard for the accurate definition of some of the terms used. In particular, the definition of biocompatibility, ‘the Williams definition’, agreed at a 1987 conference has been adopted worldwide. Now, in association with O’Donnell and Associates of Brussels, he has prepared The Williams Dictionary to provide a definitive exposition of the meaning of the terminology used in the area of biomaterials and medical devices. It includes definitions and explanations of more than 2,000 terms from many areas, including biomaterials and medical devices, materials science, biological sciences, and clinical medicine and surgery. |
| design history file example: Project Management for Mobility Engineers: Principles and Case Studies Angelo Mago, 2020-03-17 Project Management for Mobility Engineers: Principles and Case Studies provides the latest training, workshops and support consultation to Design and Development companies to optimize their New Product Development (NPD) strategies, organizational structures, and Design Document Management Systems to respond to the fast-paced and ever evolving demands and challenges facing today's mobility companies. |
| design history file example: Design of Electromechanical and Combination Products Ali Jamnia, 2023-08-31 The second edition of this work, now with the expanded title of Design of Electromechanical and Combination Products, covers the design and development of electromechanical products, updated throughout to focus not only on an Agile Systems approach but also its application to disposables and consumables. Providing a practical set of guidelines and thorough examination of best practices, this book focuses on cutting-edge research on sustainability of electromechanical and combination products. Key Features Presents the design, development, and life cycle management of electromechanical and combination products Provides a practical set of guidelines and best practices for world-class design Explains the role of costing and pricing in product design Covers Design for X and its role in product life-cycle management Examines the dynamics of cross-functional design and product development teams Develops DHF and DMR as tools and inherent components of configuration management Includes numerous real-world examples of electromechanical and combination product designs This book is intended for scientists, engineers, designers, and technical managers, and provides a gateway to developing a product’s design history file (DHF) and device master record (DMR). These tools enable the design team to communicate a product’s design, manufacturability, and service procedures with various cross-functional teams. |
| design history file example: Cytogenetic Laboratory Management Susan Mahler Zneimer, 2017-01-27 Cytogenetic Laboratory Management Cytogenetic Laboratory Management Chromosomal, FISH and Microarray-Based Best Practices and Procedures Cytogenetic Laboratory Management: Chromosomal, FISH and Microarray-Based Best Practices and Procedures is a practical guide that describes how to develop and implement best practice processes and procedures in the genetic laboratory setting. The text first describes good laboratory practices, including quality management, design control of tests, and FDA guidelines for laboratory-developed tests, and preclinical validation study designs. The second focus of the book is on best practices for staffing and training, including cost of testing, staffing requirements, process improvement using Six Sigma techniques, training and competency guidelines, and complete training programs for cytogenetic and molecular genetic technologists. The third part of the text provides stepwise standard operating procedures for chromosomal, FISH and microarray-based tests, including preanalytic, analytic, and postanalytic steps in testing, which are divided into categories by specimen type and test type. All three sections of the book include example worksheets, procedures, and other illustrative examples that can be downloaded from the Wiley website to be used directly without having to develop prototypes in your laboratory. Providing a wealth of information on both laboratory management and molecular and cytogenetic testing, Cytogenetic Laboratory Management will be an essential tool for laboratorians worldwide in the field of laboratory testing and genetic testing in particular. This book gives the essentials of: Developing and implementing good quality management programs in laboratories Understanding design control of tests and preclinical validation studies and reports FDA guidelines for laboratory-developed tests Use of reagents, instruments, and equipment Cost of testing assessment and process improvement using Six Sigma methodology Staffing training and competency objectives Complete training programs for molecular and cytogenetic technologists Standard operating procedures for all components of chromosomal analysis, FISH, and microarray testing of different specimen types This volume is a companion to Cytogenetic Abnormalities: Chromosomal, FISH and Microarray-Based Clinical Reporting. The combined volumes give an expansive approach to performing, reporting, and interpreting cytogenetic laboratory testing and the necessary management practices, staff and testing requirements. |
| design history file example: Medical Device Design Peter J. Ogrodnik, 2019-10-30 Medical Device Design: Innovation from Concept to Market, Second Edition provides the bridge between engineering design and medical device development. There is no single text that addresses the plethora of design issues a medical devices designer meets when developing new products or improving older ones; this book fills that need. It addresses medical devices' regulatory (FDA and EU) requirements, shows the essential methodologies medical designers must understand to ensure their products meet requirements, and brings together proven design protocols, thus enabling engineers and medical device manufacturers to rapidly bring new products to the marketplace. This book is unique because it takes the reader through the process of medical device development, from very early stages of conceptualization, to commercialization on the global market. This rare resource can be used by both professionals and newcomers to device design. - Provides a reference to standards and regulations that have been updated, including ISO 13485:2016, FDA regulations and the European Medical Device Regulation - Includes new case studies in the areas of classifying medical devices, the design process, quality, labeling, instructions for use, and more - Presents additional content around software and biocompatibility concerns |
| design history file example: Drug-device Combinations for Chronic Diseases SuPing Lyu, Ronald Siegel, 2015-11-04 This book covers two areas, the first detailing the concepts and technologies of drug-device combination products. The second area includes case studies of important products that either significantly shape our technologies and thinking, or contribute to current healthcare practice. The book: Discusses where drugs and devices work, where they fail, and when they need to work with each other Reviews interactions between human bodies and the drug-device combination products the measurements of these interactions Covers how a drug-device combination product is developed, tested, and regulated Includes case studies of steroid releasing leads, AOA treated tissue heart valves, intrathecal drug delivery pumps, infuse bone grafts, drug eluting stents, and antimicrobial meshes |
| design history file example: Software and Data Technologies Joaquim Filipe, Boris Shishkov, Markus Helfert, 2008-07-18 This book contains the best papers of the First International Conference on Software and Data Technologies (ICSOFT 2006), organized by the Institute for Systems and Technologies of Information, Communication and Control (INSTICC) in cooperation with the Object Management Group (OMG). Hosted by the School of Business of the Polytechnic Institute of Setubal, the conference was sponsored by Enterprise Ireland and the Polytechnic Institute of Setúbal. The purpose of ICSOFT 2006 was to bring together researchers and practitioners int- ested in information technology and software development. The conference tracks were “Software Engineering”, “Information Systems and Data Management”, “Programming Languages”, “Distributed and Parallel Systems” and “Knowledge Engineering.” Being crucial for the development of information systems, software and data te- nologies encompass a large number of research topics and applications: from imp- mentation-related issues to more abstract theoretical aspects of software engineering; from databases and data-warehouses to management information systems and kno- edge-base systems; next to that, distributed systems, pervasive computing, data quality and other related topics are included in the scope of this conference. ICSOFT included in its program a panel to discuss the future of software devel- ment, composed by six distinguished world-class researchers. Furthermore, the c- ference program was enriched by a tutorial and six keynote lectures. ICSOFT 2006 received 187 paper submissions from 39 countries in all continents. |
| design history file example: Implementing Design for Six Sigma Georgette Belair, John J. O'Neill, 2007-01-02 Have your company’s products achieved what you hoped for – rapid customer uptake, high sales volume and revenue/profit? Can you produce them at high Sigma-levels for Critical to Quality requirements, resulting in high customer satisfaction and low return/warranty costs? Authors Belair and O’Neill will help you understand how your current new-product development process is performing by diagnosing its strengths and weaknesses, and then planning and implementing changes to improve your organization’s ability to deliver Six Sigma designs!!--nl--The main goal of Implementing Design for Six Sigma is to provide you a game plan to help you “move the ball down the field” – from your current product development world to one where DFSS has been embraced as a working part of your processes and culture. Whether the products you develop are made of metal and plastic, or money and mutual funds, this book will help you improve your development process so that you may deliver better products and services that your customers will want and want to pay for. From tangible products like cars and cough syrup to service products like mortgages and retirement plans, if you dig deeply into your new-product development process and follow the guidelines in this book, you can and will implement major improvements.- |
| design history file example: Design Controls for the Medical Device Industry, Third Edition Marie B. Teixeira, 2019-08-02 This third edition provides a substantial comprehensive review of the latest design control requirements, as well as proven tools and techniques to ensure a company's design control program evolves in accordance with current industry practice. It assists in the development of an effective design control program that not only satisfies the US FDA Quality Systems Regulation (QSR) and 13485:2016 standards, but also meets today's Notified Body Auditors' and FDA Investigators' expectations. The book includes a review of the design control elements such as design planning, input, output, review, verification, validation, change, transfer, and history, as well as risk management inclusive of human factors and usability, biocompatibility, the FDA Quality System Inspection Technique (QSIT) for design controls, and medical device regulations and classes in the US, Canada, and Europe. Practical advice, methods and appendixes are provided to assist with implementation of a compliant design control program and extensive references are provided for further study. This third edition: Examines new coverage of ISO 13485-2016 design control requirements Explores proven techniques and methods for compliance Contributes fresh templates for practical implementation Provides updated chapters with additional details for greater understanding and compliance Offers an easy to understand breakdown of design control requirements Reference to MDSAP design control requirements |
| design history file example: INCOSE Needs and Requirements Manual Louis S. Wheatcraft, Michael J. Ryan, Tami Edner Katz, 2024-11-27 Complete and comprehensive manual for eliciting, defining, and managing needs and requirements, integration, verification, and validation across the lifecycle The INCOSE Needs and Requirements Manual presents product development and systems engineering practices, activities, and artifacts from the perspective of needs, requirements, verification, and validation across the system lifecycle. Composed of 16 chapters, this book provides practical guidance to help organizations understand the importance of lifecycle concepts, needs, requirements, verification, and validation activities, enabling them to successfully and effectively implement these activities during product development, systems engineering, and project management. The parent handbook published by Wiley, INCOSE Systems Engineering Handbook, divides the system lifecycle into a series of processes, with each process described in terms of a series of activities. This Manual provides more detail needed by practitioners to successfully implement these activities, with guidance and lessons learned from hundreds of years of collective experience of the authors, contributors, and reviewers. For example, while the Handbook mentions the need to define the problem statement, mission, goals, and objectives for a system, the Manual provides detailed guidance on doing so. Sample topics covered in the INCOSE Needs and Requirements Manual include: Defining the problem, opportunity, or threat and defining a mission statement, goals, objectives, and measures. Identifying external and internal stakeholders, eliciting stakeholder needs and requirements, defining drivers and constraints, and assessing risk. Performing lifecycle concept analysis and maturation and defining an integrated set of needs that represents the scope of the project. Transforming the integrated set of needs into well-formed design input requirements. Using attributes to manage needs and requirements across the lifecycle. Continuous integration, verification, and validation across the lifecycle. Moving between levels of the architecture, flow down and allocation of requirements, and budgeting performance, resource, and quality requirements. Defining the system verification and system validation success criteria, method, strategy, and responsible organizations. Planning and executing successful system verification and validation programs. Managing needs, requirements, verification, and validation across the lifecycle. Understanding the importance of an integrated, collaborative project team and effective communication between team members TheINCOSE Needs and Requirements Manual is an essential accompanying reference to the INCOSE Systems Engineering Handbook for novice and seasoned system engineers, software engineers, project managers, product developers, tool vendors, course developers, educators, trainers, customers, suppliers, non-SE stakeholders , as well as researchers and students studying systems engineering and systems design. |
| design history file example: Mastering and Managing the FDA Maze, Second Edition Gordon Harnack, 2014-04-14 The number of FDA regulations and the agencys increased expectations is staggering and their content tedious, creating a regulated industry need for compliance insight and appropriate detail. This book is the reference needed to successfully navigate through the FDA maze! The target audiences for this desk reference include: Regulatory professionals, who know their responsibility to keep their firms employees trained and competent on FDA device regulations and who need a preliminary desk reference that can be used throughout their enterprise to help train and ensure compliance Neophytes, who know nothing about FDA but need a resource that provides both broad and specific information in sufficient detail to be useful Beginners, who know a little about FDA, need to know more, and need a reference tool to help them be more effective and productive on the job Intermediates, who knows enough about FDA to know they need to know more and who need a reference tool that provides them with both more basics and executable detail Busy managers, who need to know regulatory requirements and FDA expectations in order to manage compliance in their specific activity Busy executives (CEOs, COOs, and operations managers, whom FDA holds responsible for all regulatory compliance), who also need a desk reference with specific information to quickly assess regulatory compliance, identify potential noncompliance, and review corrective, preventive, and compliance actions |
| design history file example: Neurobionics Robert K. Shepherd, 2016-08-29 Technological advances have greatly increased the potential for, and practicability of, using medical neurotechnologies to revolutionize how a wide array of neurological and nervous system diseases and dysfunctions are treated. These technologies have the potential to help reduce the impact of symptoms in neurological disorders such as Parkinson’s Disease and depression as well as help regain lost function caused by spinal cord damage or nerve damage. Medical Neurobionics is a concise overview of the biological underpinnings of neurotechnologies, the development process for these technologies, and the practical application of these advances in clinical settings. Medical Neurobionics is divided into three sections. The first section focuses specifically on providing a sound foundational understanding of the biological mechanisms that support the development of neurotechnologies. The second section looks at the efforts being carried out to develop new and exciting bioengineering advances. The book then closes with chapters that discuss practical clinical application and explore the ethical questions that surround neurobionics. A timely work that provides readers with a useful introduction to the field, Medical Neurobionics will be an essential book for neuroscientists, neuroengineers, biomedical researchers, and industry personnel. |
| design history file example: The Combination Products Handbook Susan Neadle, 2023-05-16 Combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products. According to the US Food and Drug Administration (FDA), “a combination product is one composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device and a biological product.” Examples include prefilled syringes, pen injectors, autoinjectors, inhalers, transdermal delivery systems, drug-eluting stents, and kits containing drug administration devices co-packaged with drugs and/or biological products. This handbook provides the most up-to-date information on the development of combination products, from the technology involved to successful delivery to market. The authors present important and up-to-the-minute pre- and post-market reviews of international combination product regulations, guidance, considerations, and best practices. This handbook: Brings clarity of understanding for global combination products guidance and regulations Reviews the current state-of-the-art considerations and best practices spanning the combination product lifecycle, pre-market through post-market Reviews medical product classification and assignment issues faced by global regulatory authorities and industry The editor is a recognized international Combination Products and Medical Device expert with over 35 years of industry experience and has an outstanding team of contributors. Endorsed by AAMI – Association for the Advancement of Medical Instrumentation. |
| design history file example: Biomedical Devices and Sensors Jérôme Molimard, 2024-10-08 Monitoring the human body is a key element of digital health science. Low-cost sensors derived from smartphones or smartwatches may give the impression that sensors are readily available; however, to date, very few of them are actually medical devices. Designing medical devices requires us to undertake a specific approach demanding special skills, as it concerns the integrity of the human body. The process is tightly framed by state regulations in order to ensure compliance with quality assessment, risk management and medical ethics requirements. This book aims to give biomedical students an overview on medical devices design. It firstly gives a historical and economical approach, then develops key elements in medical device design with reference to EU and US regulations, and finally describes sensors for the human body. The clinical approach is presented as the central element in medical device qualification and this offers a perspective on the use of numerical simulation, particularly since its continued growth in the USA; despite the fact that the approach is strictly limited by regulations. |
| design history file example: Implantable Neural Prostheses 2 David Zhou, Elias Greenbaum, 2010-07-10 Signi?cant progress has been made in the development of neural prostheses for restoration of human functions and improvement of the quality of life. Biomedical engineers and neuroscientists around the world are working to improve the design and performance of existing devices and to develop novel devices for arti?cial vision, arti?cial limbs, and brain-machine interfaces. This book, Implantable Neural Prostheses 2: Techniques and Engineering Approaches, is part two of a two-volume sequence that describes state-of-the-art advances in techniques associated with implantable neural prosthetic devices. The techniques covered include biocompatibility and biostability, hermetic packaging, electrochemical techniques for neural stimulation applications, novel electrode materials and testing, thin-?lm ?exible microelectrode arrays, in situ char- terization of microelectrode arrays, chip-size thin-?lm device encapsulation, microchip-embedded capacitors and microelectronics for recording, stimulation, and wireless telemetry. The design process in the development of medical devices is also discussed. Advances in biomedical engineering, microfabrication technology, and neu- science have led to improved medical-device designs and novel functions. However, many challenges remain. This book focuses on the engineering approaches, R&D advances, and technical challenges of medical implants from an engineering p- spective. We are grateful to leading researchers from academic institutes, national laboratories, as well as design engineers and professionals from the medical device industry who have contributed to the book. Part one of this series covers designs of implantable neural prosthetic devices and their clinical applications. |
| design history file example: Six Sigma for Medical Device Design Jose Justiniano, Venky Gopalaswamy, 2004-11-15 Six Sigma for Medical Device Design is the first book to apply Six Sigma principles to the design of medical devices. Authored by experienced professionals, it uses real world examples and sample plans to provide a practical how-to guide for implementation. This volume also links the Six Sigma philosophy with the FDA's Design Control and ISO regulations, useful for companies that must be compliant as well as for those in the process of implementing a quality system for design control. This book is an excellent tool for technical and scientific personnel to understand the realities of business and markets, to comply with stringent quality and safety standards, and to optimize the product realization process. |
| design history file example: Commercializing Successful Biomedical Technologies Shreefal S. Mehta, 2022-11-17 Transform your research into commercial biomedical products with this revised and updated second edition. Covering drugs, devices and diagnostics, this book provides a step-by-step introduction to the process of commercialization, and will allow you to create a realistic business plan to develop your ideas into approved biomedical technologies. This new edition includes: Over 25% new material, including practical tips on startup creation from experienced entrepreneurs. Tools for starting, growing and managing a new venture, including business planning and commercial strategy, pitching investors, and managing operations. Global real-world case studies, including emerging technologies such as regulated medical software and Artificial Intelligence (AI), offer insights into key challenges and help illustrate complex points. Tips and operational tools from established industry insiders, suitable for graduate students and new biomedical entrepreneurs. |
| design history file example: Biomaterials in the Design and Reliability of Medical Devices Michael N. Helmus, 2003-01-31 This book highlights the responsibility of medical device designers and engineers to eliminate sites of failure and to test devices to demonstrate their ultimate safety and efficacy. It also evaluates biomaterials and their properties as related to the design and reliability of medical devices. The principles that are described are readily applicable to the biomaterial scaffolds used for generating tissue-engineered constructs. |
| design history file example: Biodesign Stefanos Zenios, Josh Makower, Paul Yock, Todd J. Brinton, Uday N. Kumar, Lyn Denend, Thomas M. Krummel, 2009-09-25 Recognize market opportunities, master the design process, and develop business acumen with this 'how-to' guide to medical technology innovation. A three-step, proven approach to the biodesign innovation process - identify, invent, implement - provides a practical formula for innovation. The experiences of hundreds of innovators and companies, in the form of case studies, quotes and practical advice, offer a realistic, action-orientated roadmap for successful biodesign innovation. Real-world examples, end-of-chapter projects, and Getting Started sections guide the reader through each of the key stages of the process and provide a template to create their own new medical devices. Addressing common medical, engineering, and business challenges to develop well-rounded expertise, this book is the complete package for any biodesign entrepreneur. The text is supported by valuable resources, including up-to-date industry changes: found at ebiodesign.org. |
| design history file example: Development of FDA-Regulated Medical Products Elaine Whitmore, 2012-02-15 Translating promising discoveries and innovations into useful, marketable medical products demands a robust process to guide nascent products through a tangle of scientific, clinical, regulatory, economic, social, and legal challenges. There are so many human and environmental elements involved in shepherding medical advances from lab to launch that the field of medical product development has been referred to as an ecosystem. The purpose of this book is to help provide a shared foundation from which cross-functional participants in that ecosystem can negotiate the product development labyrinth and accomplish the goal of providing both groundbreaking and iterative new medical products. The book is intended for anyone in industry, the public sector, or academia—regardless of functional specialty, workplace, or seniority—who is interested in medical product development. The years since the publication of the previous edition of this book have seen profound changes in the actions and attitudes of patients, insurers, manufacturers, and the Food and Drug Administration regarding the streamlining of medical product development and approval. What those years have not seen is a concomitant increase in innovative treatments with profound benefits to patients. Despite enormous investments in research by both private and public sources and a surge in scientific and technological advances, new medical products barely trickle into the marketplace. For a variety of reasons, applied sciences necessary for medical product development are not keeping pace with the tremendous advances in basic sciences. Not surprisingly, industry and academia are under substantial pressure to transform discoveries and innovations from the laboratory into safe and effective medical products to benefit patients and improve health. This evolution—from bench to bedside—has become known as translational research and development, and this approach is what this book illuminates. I have been working in medical device design and design assurance for over 10 years...Elaine Whitmore really gets this right...The point is that quality regulations are not going to go away, and those responsible for healthcare product development will have to lead the charge to keep up the momentum in their organizations. I am going to have to buy several copies of this for my clients! Joseph P. Sener, P.E. |
White Paper Design History Files – Examples - pathwise.com
Examples will be provided to demonstrate use as well as relevant Design History File documentation. What is a Design History File (DHF)? As discussed in Design History Files – …
Assembling a Design History File for your medical device
Facing an ISO 13485 or FDA 21 CFR 820 audit? Your Design History File (DHF) is an invaluable piece of the puzzle. A good DHF is a logical, structured and ordered compilation of your …
Design Controls - U.S. Food and Drug Administration
• Establish and maintain a design history file for each type of device. • Include in the DHF, or reference records information necessary to demonstrate that the design was developed
Design History File - RMRAS
Design History File (DHF) Definition: A compilation of records which describes the design history of a finished product. It should provide objective evidence that design controls were followed. …
D-722-2-1 DESIGN HISTORY FILE V1 Page 1 of 4 - vee-med.com
maintain a design history for each type of device. The new 13485:2016 requires manufacturer to maintain a design and development file for each medical device type or medical device family. …
Design history file example
A Design History File (DHF) is a collection of documents that outlines the design history of a medical device. This document is one of the first things regulatory bodies like the FDA inspect …
Design history file template easyQ
DESIGN HISTORY FILE TEMPLATE Product Name Mention the Product Name Product Version/Model Number Mention the System Version/ Model number DHF Version Mention the …
Design History File Example Copy - archive.ncarb.org
Design History File Example: DESIGN CONTROLS, RISK MANAGEMENT & PROCESS VALIDATION FOR MEDICAL DEVICE PROFESSIONALS Vernon Geckler,2017-02-11 This …
DESIGN HISTORY FILE REMEDIATION FOR MEDICAL DEVICES
Design History File was introduced as a part of the Safe Medical Device Act passed by the American Congress in 1990. A Design History File (DHF) is a compilation of documentation …
DESIGN HISTORY FILE UPDATED
To update the compilation of documentation that describes the design history of a finished medical device. The DHF contains or references the records necessary to demonstrate that the design …
Documents, Change Control and Records - U.S. Food and …
Design history file (DHF) compilation of records which describes design history of a finished device [21 CFR 820.3(e)] CFR = Code of Federal Regulations
PD233: Design of Biomedical Devices and Systems - Centre …
Design history file (DHF) •DHF is a compilation of records, which describes the design history of a finished device. •It covers the design activities used to develop the device, accessories, major …
PHASE 5 QUALIFICATION Deliverable 25 ~ Design History File …
The design history file (DHF) documents and describes the steps taken throughout the design process to create your medical device. The DHF is a record of the process including all plans, …
White Paper Design History Files Design Control …
This White Paper focuses on Design Control compliance for Medical Devices per 21 CFR 820.30 and ISO 13485: 2016 § 7.3, including Design History File documentation. What is a Design …
DMR-Device Master Record vs DHF-Design History File vs …
Here's my simple definition for DHF, DMR, and DHR. The Design History File explains how you developed the recipe for making your device. The Device Master Record is the recipe itself …
Design History File Example Copy - archive.ncarb.org
Design History File Example: DESIGN CONTROLS, RISK MANAGEMENT & PROCESS VALIDATION FOR MEDICAL DEVICE PROFESSIONALS Vernon Geckler,2017-02-11 This …
Design History File Example (PDF) - archive.ncarb.org
Design History File Example: DESIGN CONTROLS, RISK MANAGEMENT & PROCESS VALIDATION FOR MEDICAL DEVICE PROFESSIONALS Vernon M. Geckler,2017-02-11 This …
Design History File Example (2024) - staging …
Design History File Example: DESIGN CONTROLS, RISK MANAGEMENT & PROCESS VALIDATION FOR MEDICAL DEVICE PROFESSIONALS Vernon M. Geckler,2017-02-11 This …
Design Controls – Joe Tartal - U.S. Food and Drug …
Document results of the design review in the Design History File, or DHF, and include the identification of the design, the date, and the names of the individuals performing the review.
Design History File Example (book) - archive.ncarb.org
insights on familiar figures such as Harley Earl and Norman Bel Geddes and shed new light on neglected aspects of design history such as the history of women in early American graphic …
White Paper Design History Files – Examples - pathwise.com
Examples will be provided to demonstrate use as well as relevant Design History File documentation. What is a Design History File (DHF)? As discussed in Design History Files – …
Assembling a Design History File for your medical device
Facing an ISO 13485 or FDA 21 CFR 820 audit? Your Design History File (DHF) is an invaluable piece of the puzzle. A good DHF is a logical, structured and ordered compilation of your medical device …
Design Controls - U.S. Food and Drug Administration
• Establish and maintain a design history file for each type of device. • Include in the DHF, or reference records information necessary to demonstrate that the design was developed
Design History File - RMRAS
Design History File (DHF) Definition: A compilation of records which describes the design history of a finished product. It should provide objective evidence that design controls were followed. The …
D-722-2-1 DESIGN HISTORY FILE V1 Page 1 of 4 - vee …
maintain a design history for each type of device. The new 13485:2016 requires manufacturer to maintain a design and development file for each medical device type or medical device family. …
Design history file example
A Design History File (DHF) is a collection of documents that outlines the design history of a medical device. This document is one of the first things regulatory bodies like the FDA inspect when …
Design history file template easyQ
DESIGN HISTORY FILE TEMPLATE Product Name Mention the Product Name Product Version/Model Number Mention the System Version/ Model number DHF Version Mention the DHF version (Start …
Design History File Example Copy - archive.ncarb.org
Design History File Example: DESIGN CONTROLS, RISK MANAGEMENT & PROCESS VALIDATION FOR MEDICAL DEVICE PROFESSIONALS Vernon Geckler,2017-02-11 This handbook provides the …
DESIGN HISTORY FILE REMEDIATION FOR MEDICAL DEVICES
Design History File was introduced as a part of the Safe Medical Device Act passed by the American Congress in 1990. A Design History File (DHF) is a compilation of documentation that describes …
DESIGN HISTORY FILE UPDATED
To update the compilation of documentation that describes the design history of a finished medical device. The DHF contains or references the records necessary to demonstrate that the design …
Documents, Change Control and Records - U.S. Food and …
Design history file (DHF) compilation of records which describes design history of a finished device [21 CFR 820.3(e)] CFR = Code of Federal Regulations
PD233: Design of Biomedical Devices and Systems
Design history file (DHF) •DHF is a compilation of records, which describes the design history of a finished device. •It covers the design activities used to develop the device, accessories, major …
PHASE 5 QUALIFICATION Deliverable 25 ~ Design History …
The design history file (DHF) documents and describes the steps taken throughout the design process to create your medical device. The DHF is a record of the process including all plans, …
White Paper Design History Files Design Control …
This White Paper focuses on Design Control compliance for Medical Devices per 21 CFR 820.30 and ISO 13485: 2016 § 7.3, including Design History File documentation. What is a Design History File …
DMR-Device Master Record vs DHF-Design History File vs …
Here's my simple definition for DHF, DMR, and DHR. The Design History File explains how you developed the recipe for making your device. The Device Master Record is the recipe itself …
Design History File Example Copy - archive.ncarb.org
Design History File Example: DESIGN CONTROLS, RISK MANAGEMENT & PROCESS VALIDATION FOR MEDICAL DEVICE PROFESSIONALS Vernon Geckler,2017-02-11 This handbook provides the …
Design History File Example (PDF) - archive.ncarb.org
Design History File Example: DESIGN CONTROLS, RISK MANAGEMENT & PROCESS VALIDATION FOR MEDICAL DEVICE PROFESSIONALS Vernon M. Geckler,2017-02-11 This handbook provides …
Design History File Example (2024) - staging …
Design History File Example: DESIGN CONTROLS, RISK MANAGEMENT & PROCESS VALIDATION FOR MEDICAL DEVICE PROFESSIONALS Vernon M. Geckler,2017-02-11 This handbook provides …
Design Controls – Joe Tartal - U.S. Food and Drug …
Document results of the design review in the Design History File, or DHF, and include the identification of the design, the date, and the names of the individuals performing the review.
Design History File Example (book) - archive.ncarb.org
insights on familiar figures such as Harley Earl and Norman Bel Geddes and shed new light on neglected aspects of design history such as the history of women in early American graphic …
