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| design history file fda: 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. |
| design history file fda: Design Controls for the Medical Device Industry Marie Teixeira, Richard Bradley, 2002-09-20 This reference provides real-world examples, strategies, and templates for the implementation of effective design control programs that meet current ISO 9000 and FDA QSR standards and regulations-offering product development models for the production of safe, durable, and cost-efficient medical devices and systems. Details procedures utilize |
| design history file fda: The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices Amiram Daniel, 2008-01-01 How have recent changes in domestic and international regulations affected quality management in the development and marketing of medical devices in the US and abroad? Consultants Daniel and Kimmelman take a close look at the Quality System Regulation (QsReg), the ISO 13485: 2003 standard and the ISO/TR 14969: 2004 guidance document as well as a number of US Food and Drug Administration (FDA) and Global Harmonization Task Force (GHTF) guidance documents. The authors provide extensive commentary and notes an update their material to include such topics as the incorporation of principles of risk management into the medical device organizations' quality management systems (QMSs) and considerations of combination products. Daniel and Kimmelman include full coverage of the QSReg requirements, descriptions of comparable requirements in the ISO documents, excerpts of the FDA's responses to the QSReg preamble and excerpts from FDA guidance documents related to QMSs. |
| design history file fda: 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 fda: Interpretation of FDA's Quality System Regulations (QSR) With QSIT references , |
| design history file fda: 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 fda: Pre-Production Quality Assurance for Healthcare Manufacturers G. William Hough, David A. Rawlings, Michael F. Turner, 1997-06-30 The FDA and ISO 9001 require manufacturers to institute comprehensive and rigorous pre-production quality assurance processes to assure that design defects will be eliminated prior to manufacture and product sale. Pre-Production Quality Assurance for Healthcare Manufacturers addresses the product design and development phases for a medical product life cycle and shows how this effort can be successfully undertaken in accord with current Good Practice and ISO 9001. The authors provide a detailed step-by-step approach to ensuring that effective pre-production quality assurance is established and effectively in place and explore the key concepts of design, product, and process. |
| design history file fda: Medical Devices and the Public's Health Institute of Medicine, Board on Population Health and Public Health Practice, Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process, 2011-11-25 Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework. |
| design history file fda: 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 fda: 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 fda: Regulatory Affairs for Biomaterials and Medical Devices Stephen F. Amato, Robert M. Ezzell Jr, 2014-10-27 All biomaterials and medical devices are subject to a long list of regulatory practises and policies which must be adhered to in order to receive clearance. This book provides readers with information on the systems in place in the USA and the rest of the world. Chapters focus on a series of procedures and policies including topics such as commercialization, clinical development, general good practise manufacturing and post market surveillance. - Addresses global regulations and regulatory issues surrounding biomaterials and medical devices - Especially useful for smaller companies who may not employ a full time vigilance professional - Focuses on procedures and policies including risk management, intellectual protection, marketing authorisation, university patent licenses and general good practise manufacturing |
| design history file fda: Public Health Effectiveness of the FDA 510(k) Clearance Process Institute of Medicine, Board on Population Health and Public Health Practice, Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process, 2010-10-04 The Food and Drug Administration (FDA) is responsible for assuring that medical devices are safe and effective before they go on the market. As part of its assessment of FDA's premarket clearance process for medical devices, the IOM held a workshop June 14-15 to discuss how to best balance patient safety and technological innovation. This document summarizes the workshop. |
| design history file fda: Device Inspections Guide , 2003 |
| design history file fda: 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 fda: 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 fda: NASA Tech Briefs , 2001 |
| design history file fda: 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 fda: Medical Device Rommel Garcia, 2017-06-06 This book is meant to be a guide to all who want to learn about a highly regulated industry. My approach is to give you, the reader, an example of a fictitious device, and we will take it from a conceptual idea all the way to launch and beyond. My intention is to incorporate the best experiences that I and other contributors have had into this book and convert them into laymans terms for those who are in need. These experiences can and will be indispensable to beginners and professionals alike who are trying their hand in the medical device industry and to those who have not been out of their silo to help see how each of the systems relate to each as a whole. However, it should be noted that the contents of this book should be taken only as information and is not intended to demonstrate how companies can be in compliance. In some instances, there are multiple ways to go through the maze of regulations that are documented and made by agencies because the regulations are pretty much made and designed to be flexible and high level so that companies can adopt their systems, which are solely designed for their purposes. Therefore, this book will try to avoid complicated words and complex technical details of engineering and statistics. This book will strive to be an embodiment of the honest-to-goodness, everyday experiences and issues that folks experience while working in the medical device industry. |
| design history file fda: Introduction to Biomedical Engineering John Enderle, Joseph Bronzino, Susan M. Blanchard, 2005-04-06 New, revised edition of the most comprehensive book for bioengineering students and professionals. -- Prové de l'editor. |
| design history file fda: Handbook of Neuroengineering Nitish V. Thakor, 2023-02-02 This Handbook serves as an authoritative reference book in the field of Neuroengineering. Neuroengineering is a very exciting field that is rapidly getting established as core subject matter for research and education. The Neuroengineering field has also produced an impressive array of industry products and clinical applications. It also serves as a reference book for graduate students, research scholars and teachers. Selected sections or a compendium of chapters may be used as “reference book” for a one or two semester graduate course in Biomedical Engineering. Some academicians will construct a “textbook” out of selected sections or chapters. The Handbook is also meant as a state-of-the-art volume for researchers. Due to its comprehensive coverage, researchers in one field covered by a certain section of the Handbook would find other sections valuable sources of cross-reference for information and fertilization of interdisciplinary ideas. Industry researchers as well as clinicians using neurotechnologies will find the Handbook a single source for foundation and state-of-the-art applications in the field of Neuroengineering. Regulatory agencies, entrepreneurs, investors and legal experts can use the Handbook as a reference for their professional work as well. |
| design history file fda: Safe Medical Devices Act of 1990 United States. Congress, 1990 |
| design history file fda: Communicating Clearly About Medicines National Academies of Sciences, Engineering, and Medicine, Health and Medicine Division, Board on Population Health and Public Health Practice, Roundtable on Health Literacy, 2017-09-08 Research conducted over the past two decades has shown that poor patient understanding of medication instructions is an important contributor to the more than 1 million medication errors and adverse drug events that lead to office and emergency room visits, hospitalizations, and even death. Patients who have limited literacy skills, who have multiple comorbidities, and who are elderly face the greatest risk, and limited literacy skills are significantly associated with inadequate understanding and use of prescription instructions and precautions. The Agency for Healthcare Research and Quality notes that only 12 percent of U.S. adults have proficient health literacy that allows them to interpret a prescription label correctly. Given the importance of health literacy to the proper use of medications, and the apparent lack of progress in improving medication adherence, the Roundtable on Health Literacy formed an ad hoc committee to plan and conduct a 1-day public workshop that featured invited presentations and discussion of the role and challenges regarding clarity of communication on medication. Participants focused on using health literacy principles to address clarity of materials, decision aids, and other supportive tools and technologies regarding risks, benefits, alternatives, and health plan coverage. This publication summarizes the presentations and discussions from the workshop. |
| design history file fda: Materials and Design Michael F. Ashby, Kara Johnson, 2009-10-28 Materials and Design: The Art and Science of Material Selection in Product Design, Second Edition, discusses the role of materials and processes in product design. The book focuses on the materials that designers need, as well as on how and why they use them. The book's 10 chapters cover topics such as function and personality, factors influencing product design, the design process, materials selection, and case studies in materials and design. Appendices for each chapter provide exercises for readers, along with detailed charts of technical attributes of different materials for reference. This book will be particularly useful to both students and working designers. Students are introduced to the role of materials in manufacturing and design, with the help of familiar language and concepts. Working designers can use the book as a reference source for materials and manufacturing. - The best guide ever published on the on the role of materials, past and present, in product development, by noted materials authority Mike Ashby and professional designer Kara Johnson--now with even better photos and drawings on the Design Process - Significant new section on the use of re-cycled materials in products, and the importance of sustainable design for manufactured goods and services - Enhanced materials profiles, with addition of new materials types like nanomaterials, advanced plastics and bio-based materials |
| design history file fda: Medical Device Regulation Elijah Wreh, 2023-02-22 Medical Device Regulation provides the current FDA-CDRH thinking on the regulation of medical devices. This book offers information on how devices meet criteria for being a medical device, which agencies regulate medical devices, how policies regarding regulation affect the market, rules regarding marketing, and laws and standards that govern testing. This practical, well-structured reference tool helps medical device manufacturers both in and out of the United States with premarket application and meeting complex FDA regulatory requirements. The book delivers a comprehensive overview of the field from an author with expertise in regulatory affairs and commercialization of medical devices. - Offers a unique focus on the regulatory affairs industry, specifically targeted at regulatory affairs professionals and those seeking certification - Puts regulations in the context of contemporary design - Includes case studies and applications of regulations |
| design history file fda: 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 fda: 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 fda: Integrated Pharmaceutics Antoine Al-Achi, Mali Ram Gupta, William Craig Stagner, 2022-09-21 This work is an examination of all aspects of the science in developing effective dosage form for drug delivery Pharmaceutics refers to the subfield of pharmaceutical sciences that develops drug delivery products or devices to optimize the drug's performance once administered. This multidisciplinary field draws on physical chemistry, organic chemistry, and biophysics to generate and refine these crucial elements of medical care. Moreover, incorporating such disparate dimensions of drug product design as material properties and legal regulation bridges the gap between effective chemicals and viable medical treatments. Integrated Pharmaceutics provides a comprehensive introduction to the creation and manufacture of effective dosage forms for drug delivery. It presents its subject following the principles of physical pharmacy, product design, and drug regulations. This tripartite structure allows readers to move from theory to practice, beginning from a firm foundation of physical pharmacy principles, including drug solubility and stability estimation, rheology, and interfacial properties. From there, it proceeds to discussions of drug product design and of harmonizing pharmaceutical design with the regulatory regimens and technological standards of the United States, European Union, and Japan. Readers of the second edition of Integrated Pharmaceutics will also find: A glossary defining key terms, extensive informative appendices, and a list of references leading to the primary literature in the field for each chapter Earlier chapters are expanded, with additional new chapters including one entitled “Biotechnology Products” Supplementary instructor guide with questions and solutions available online for registered professors Updated regulatory guidelines including quality by design, design space analysis, process analytical technology, polymorphism characterization, blend sample uniformity, and stability protocols Integrated Pharmaceutics is a useful textbook for graduate students in pharmaceutical sciences, drug formulation and design, and biomedical engineering. In addition, professionals in the pharmaceutical industry, including regulatory bodies, will find it a helpful reference guide. |
| design history file fda: Medical Device Quality Management Systems Susanne Manz, 2018-09-27 Medical Devices Quality Management Systems: Strategy and Techniques for Improving Efficiency and Effectiveness is written for the needs of quality, compliance, and regulatory professionals in medical device companies. It includes secrets for developing an effective, yet efficient, Quality Management System (QMS) and explains how to create a vision, strategy, and tactical plans. Author Manz shares lessons on leadership, key roles and responsibilities within a medical device company, while also exploring the concepts of process ownership, individual accountability, and how to cultivate a culture of quality and compliance. This book is useful for all executive, functional leaders, and organizations in the highly regulated medical device industry. - Provides practical, real-world guidance on developing an effective and efficient Quality Management System - Presents a roadmap for QMS development - Covers techniques to assess current state - Includes discussions on tools, such as CAPA and Six Sigma that help define vision, strategy and quality plans |
| design history file fda: Plastics in Medical Devices Vinny R. Sastri, 2013-11-27 Plastics in Medical Devices is a comprehensive overview of the main types of plastics used in medical device applications. It focuses on the applications and properties that are most important in medical device design, such as chemical resistance, sterilization capability and biocompatibility. The roles of additives, stabilizers, and fillers as well as the synthesis and production of polymers are covered and backed up with a wealth of data tables. Since the first edition the rate of advancement of materials technology has been constantly increasing. In the new edition Dr. Sastri not only provides a thorough update of the first edition chapters with new information regarding new plastic materials, applications and new requirements, but also adds two chapters – one on market and regulatory aspects and supplier controls, and one on process validation. Both chapters meet an urgent need in the industry and make the book an all-encompassing reference not found anywhere else. - Comprehensive coverage of uses of polymers for medical devices - Unique coverage of medical device regulatory aspects, supplier control and process validation - Invaluable guide for engineers, scientists and managers involved in the development and marketing of medical devices and materials for use in medical devices |
| design history file fda: Handbook of Polymer Applications in Medicine and Medical Devices Vinny R. Sastri, 2013-12-05 Over the past 2000 years, many devices have been developed and used in the mitigation and diagnosis of diseases. The materials used in these devices have ranged from stone, wood, metal, ceramics, and most recently plastics. Medical devices have also evolved in sophistication and complexity over time. With the formalization of the scientific method in the seventeenth century such devices became more prevalent [1]. Many medical devices were manufactured by doctors or small companies and sold directly to the public with no government standards or oversight. With the explosion of medical technology in the early twentieth century, several intermediaries had evolved between the medical device industry and the public. In 1879, Dr E.R. Squibb, in an address to the Medical Society of the State of New York, proposed the enactment of a national statute to regulate food and drugs [2]. It was not until 27 years later that the Food and Drug Act of 1906 was introduced into the Congress and signed into law by President Theodore Roosevelt [3]. At that time, devices that were harmful to human safety and health proliferated the market but regulation of medical devices by the Bureau of Chemistry (the precursor to the Food and Drug Administration—FDA) was limited to challenging commercial products only after they had been released into the market. Devices in the marketplace that were defective, adulterated, or misbranded were seized and the device manufacturers were prosecuted in a court of law, but only after the products were sold in the market and caused harm to the end users. Thus, there was a strong need for regulating the devices before they entered the marketplace. An FDA report [4], issued in September 1970, detailed as many as 10,000 injuries and 731 deaths from ineffective medical devices. The report recommended the formation of a regulatory system and body that would enforce the production and sale of safe and effective devices to the public. All medical devices already on the market would be inventoried and classified into a three-tiered system based on their criticality of end use. It also detailed requirements for records and reports, registration and inspection of establishments, and uniform quality assurance programs called good manufacturing practices (GMP). After much lobbying by the FDA, Senate bill SR 510, “The Medical Device Amendments of 1973” was introduced by Senator Edward M. Kennedy and was passed by the Senate in 1975. House bill HR 11124, introduced by Representative Paul Rogers, was passed by the House in 1976. These bills eventually became the Medical Device Amendments of 1976, and were signed into law by President Nixon. The Medical Device Amendments of 1976 became the basis for the medical device regulation in the United States to control and regulate the production of finished devices and thus the device manufacturers themselves. |
| design history file fda: Machine Design , 1998 |
| design history file fda: Quality Assurance in Dialysis L.W. Henderson, R.S. Thuma, 2007-07-23 In examining the preface of our first book, it is increases needed. The Deming philosophy empha apparent that the editorial comments made in sizes that quality is never fully achieved: process 1994 are even more pertinent in today's cost- improvement is never ending. constrained healthcare environment than when But, what is quality? Without defining, David first written. We repeat them in part. Garvin makes the point that in its original form, This is a time in history when the concept of quality activities were reactive and inspecti- quality is reaching new highs in terms of public oriented; today, quality related activities have awareness. Articles describing quality, CQI, qual broadened and are seen as essential for strategic ity tools, critical success factors, failures, and success [1]. How can the broad context of quality lessons learned appear in local newspapers, trade be applied to the diverse aspects of ESRD? journals, scientific periodicals, and professional Furthermore, although far from a new concept, publications on a daily basis, yet implementation Continuous Quality Improvement (CQI) has taken of a quality system in many hospital units is its place as a dominant theme in many industries. approached with caution and the basic tenants of CQI is more broadly applicable, both in concept quality systems and CQI continue to be misunder and execution, to service as well as manufacturi- stood. based operations. |
| design history file fda: Designing Usability into Medical Products Michael E. Wiklund, Stephen B. Wilcox, 2005-02-11 Advocating a user-centered approach to medical technology design, Designing Usability into Medical Products covers the essential processes and specific techniques necessary to produce safe, effective, usable, and appealing medical systems and products. Written by experts on user-centered research, design, and evaluation, the book provides a range o |
| design history file fda: Biodesign Stefanos Zenios, Josh Makower, Paul Yock, 2010 Recognize market opportunities, master the design process, and develop business acumen with this 'how-to' guide to medical technology innovation. Outlining a systematic, proven approach for innovation - identify, invent, implement - and integrating medical, engineering, and business challenges with real-world case studies, this book provides a practical guide for students and professionals. |
| design history file fda: Pharmaceutical Dosage Forms - Parenteral Medications Sandeep Nema, John D. Ludwig, 2016-04-19 This three-volume set of Pharmaceutical Dosage Forms: Parenteral Medications is an authoritative, comprehensive reference work on the formulation and manufacture of parenteral dosage forms, effectively balancing theoretical considerations with the practical aspects of their development. As such, it is recommended for scientists and engineers in the |
| design history file fda: Managing Medical Devices within a Regulatory Framework Beth Ann Fiedler, 2016-09-10 Managing Medical Devices within a Regulatory Framework helps administrators, designers, manufacturers, clinical engineers, and biomedical support staff to navigate worldwide regulation, carefully consider the parameters for medical equipment patient safety, anticipate problems with equipment, and efficiently manage medical device acquisition budgets throughout the total product life cycle. This contributed book contains perspectives from industry professionals and academics providing a comprehensive look at health technology management (HTM) best practices for medical records management, interoperability between and among devices outside of healthcare, and the dynamics of implementation of new devices. Various chapters advise on how to achieve patient confidentiality compliance for medical devices and their software, discuss legal issues surrounding device use in the hospital environment of care, the impact of device failures on patient safety, methods to advance skillsets for HTM professionals, and resources to assess digital technology. The authors bring forth relevant challenges and demonstrate how management can foster increased clinical and non-clinical collaboration to enhance patient outcomes and the bottom line by translating the regulatory impact on operational requirements. - Covers compliance with FDA and CE regulations, plus EU directives for service and maintenance of medical devices - Provides operational and clinical practice recommendations in regard to regulatory changes for risk management - Discusses best practices for equipment procurement and maintenance - Provides guidance on dealing with the challenge of medical records management and compliance with patient confidentiality using information from medical devices |
| design history file fda: Safe Medical Devices for Children Institute of Medicine, Board on Health Sciences Policy, Committee on Postmarket Surveillance of Pediatric Medical Devices, 2006-01-20 Innovative medical devices have helped reduce the burden of illness and injury and improve the quality of life for countless children. Mechanical ventilators and other respiratory support devices rescue thousands of fragile newborns every year. Children who once would have died of congenital heart conditions survive with the aid of implanted pacemakers, mechanical heart valves, and devices that close holes in the heart. Responding to a Congressional request, the Institute of Medicine assesses the system for postmarket surveillance of medical devices used with children. The book specifically examines: The Food and Drug Administration's monitoring and use of adverse event reports The agency's monitoring of manufacturers' fulfillment of commitments for postmarket studies ordered at the time of a device's approval for marketing The adequacy of postmarket studies of implanted devices to evaluate the effects of children's active lifestyles and their growth and development on device performance Postmarket surveillance of medical devices used with children is a little investigated topic, in part because the market for most medical products is concentrated among older adults. Yet children differ from adults, and their special characteristics have implications for evaluation and monitoring of the short- and long-term safety and effectiveness of medical devices used with young patients. |
| design history file fda: 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 fda: Challenges in Protein Product Development Nicholas W. Warne, Hanns-Christian Mahler, 2018-06-20 In this volume, the authors discuss the many significant challenges currently faced in biotechnology dosage form development, providing guidance, shared experience and thoughtful reflection on how best to address these potential concerns. As the field of therapeutic recombinant therapeutic proteins enters its fourth decade and the market for biopharmaceuticals becomes increasingly competitive, companies are increasingly dedicating resources to develop innovative biopharmaceuticals to address unmet medical needs. Often, the pharmaceutical development scientist is encountering challenging pharmaceutical properties of a given protein or by the demands placed on the product by stability, manufacturing and preclinical or clinical expectations, as well as the evolving regulatory expectations and landscape. Further, there have been new findings that require close assessment, as for example those related to excipient quality, processing, viscosity and device compatibility and administration, solubility and opalescence and container-closure selection. The literature varies widely in its discussion of these critical elements and consensus does not exist. This topic is receiving a great deal of attention within the biotechnology industry as well as with academic researchers and regulatory agencies globally. Therefore, this book is of interest for business leaders, researchers, formulation and process development scientists, analytical scientists, QA and QC officers, regulatory staff, manufacturing leaders and regulators active in the pharmaceutical and biotech industry, and expert reviewers in regulatory agencies. |
| design history file fda: Materials Experience Elvin Karana, Owain Pedgley, Valentina Rognoli, 2013-10-24 There currently exists an abundance of materials selection advice for designers suited to solving technical product requirements. In contrast, a stark gap can be found in current literature that articulates the very real personal, social, cultural and economic connections between materials and the design of the material world. In Materials Experience: Fundamentals of Materials and Design, thirty-four of the leading academicians and experts, alongside 8 professional designers, have come together for the first time to offer their expertise and insights on a number of topics common to materials and product design. The result is a very readable and varied panorama on the world of materials and product design as it currently stands. - Contributions by many of the most prominent materials experts and designers in the field today, with a foreword by Mike Ashby - The book is organized into 4 main themes: sustainability, user interaction, technology and selection - Between chapters, you will find the results of interviews conducted with internationally known designers - These 'designer perspectives' will provide a 'time out' from the academic articles, with emphasis placed on fascinating insights, product examples and visuals |
Strang
STRANG is a Miami-based design firm renowned for advancing the principles of Environmental Modernism in extraordinary locations around the world. This concept, dubbed by the firm, …
Angel Oaks | Strang
STRANG is a Miami-based design firm renowned for advancing the principles of Environmental Modernism in extraordinary locations around the world. This concept, dubbed by the firm, …
Rock House | Strang - strang.design
STRANG is a Miami-based design firm renowned for advancing the principles of Environmental Modernism in extraordinary locations around the world. This concept, dubbed by the firm, …
Kiaora Residence | Strang
STRANG is a Miami-based design firm renowned for advancing the principles of Environmental Modernism in extraordinary locations around the world. This concept, dubbed by the firm, …
INSIDE NATURE - strang.design
102 FLORIDA DESIGN’S MIAMI EDITION 21-1 above: In the primary bathroom, the spa shower is made of Italian limestone while the floor is a mosaic of pebble tiles. As with all the Florida …
Elbow Cay Residence | Strang - strang.design
STRANG is a Miami-based design firm renowned for advancing the principles of Environmental Modernism in extraordinary locations around the world. This concept, dubbed by the firm, …
Beyond Vernacularity: Lessons of Elemental Modernism | Strang
STRANG is a Miami-based design firm renowned for advancing the principles of Environmental Modernism in extraordinary locations around the world. This concept, dubbed by the firm, …
Irvine Residence | Strang - strang.design
STRANG is a Miami-based design firm renowned for advancing the principles of Environmental Modernism in extraordinary locations around the world. This concept, dubbed by the firm, …
Team | Strang
STRANG is a Miami-based design firm renowned for advancing the principles of Environmental Modernism in extraordinary locations around the world. This concept, dubbed by the firm, …
Hill Residence | Strang
STRANG is a Miami-based design firm renowned for advancing the principles of Environmental Modernism in extraordinary locations around the world. This concept, dubbed by the firm, …
Strang
STRANG is a Miami-based design firm renowned for advancing the principles of Environmental Modernism in extraordinary locations around the world. This concept, dubbed by the firm, …
Angel Oaks | Strang
STRANG is a Miami-based design firm renowned for advancing the principles of Environmental Modernism in extraordinary locations around the world. This concept, dubbed by the firm, …
Rock House | Strang - strang.design
STRANG is a Miami-based design firm renowned for advancing the principles of Environmental Modernism in extraordinary locations around the world. This concept, dubbed by the firm, …
Kiaora Residence | Strang
STRANG is a Miami-based design firm renowned for advancing the principles of Environmental Modernism in extraordinary locations around the world. This concept, dubbed by the firm, …
INSIDE NATURE - strang.design
102 FLORIDA DESIGN’S MIAMI EDITION 21-1 above: In the primary bathroom, the spa shower is made of Italian limestone while the floor is a mosaic of pebble tiles. As with all the Florida …
Elbow Cay Residence | Strang - strang.design
STRANG is a Miami-based design firm renowned for advancing the principles of Environmental Modernism in extraordinary locations around the world. This concept, dubbed by the firm, …
Beyond Vernacularity: Lessons of Elemental Modernism | Strang
STRANG is a Miami-based design firm renowned for advancing the principles of Environmental Modernism in extraordinary locations around the world. This concept, dubbed by the firm, …
Irvine Residence | Strang - strang.design
STRANG is a Miami-based design firm renowned for advancing the principles of Environmental Modernism in extraordinary locations around the world. This concept, dubbed by the firm, …
Team | Strang
STRANG is a Miami-based design firm renowned for advancing the principles of Environmental Modernism in extraordinary locations around the world. This concept, dubbed by the firm, …
Hill Residence | Strang
STRANG is a Miami-based design firm renowned for advancing the principles of Environmental Modernism in extraordinary locations around the world. This concept, dubbed by the firm, …
