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| gap analysis medical device: Registries for Evaluating Patient Outcomes Agency for Healthcare Research and Quality/AHRQ, 2014-04-01 This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews. |
| gap analysis medical device: Medical Devices World Health Organization, 2010 Background papers 1 to 9 published as technical documents. Available in separate records from WHO/HSS/EHT/DIM/10.1 to WHO/HSS/EHT/DIM/10.9 |
| gap analysis medical device: The Medical Device Industry John Burton, 2009-03-26 The Medical Device industry is one of the fastest growing industries in the world. Device manufacturers are producing increasingly sophisticated and complex medical device software to differentiate themselves in the battle for dominance in this sector. The increase in the complexity of medical device software has introduced new challenges with respect to making medical devices and their associated software safe. Risk management has emerged as key in addressing these challenges. Existing literature on risk management for medical devices has been slow to adequately account for the complex nature of software in modern medical devices. Conversely, excellent progress has been made in the broader Software Engineering community with the production of holistic software risk based models such as the Capability Maturity Model Integration (CMMI®) and SPICE™. However, these models do not account for medical device specific requirements. This book examines the possibility of a unified approach whilst investigating the relevance of the CMMI® SPI model to the medical device regulatory requirements. |
| gap analysis medical device: Improving Diagnosis in Health Care National Academies of Sciences, Engineering, and Medicine, Institute of Medicine, Board on Health Care Services, Committee on Diagnostic Error in Health Care, 2015-12-29 Getting the right diagnosis is a key aspect of health care - it provides an explanation of a patient's health problem and informs subsequent health care decisions. The diagnostic process is a complex, collaborative activity that involves clinical reasoning and information gathering to determine a patient's health problem. According to Improving Diagnosis in Health Care, diagnostic errors-inaccurate or delayed diagnoses-persist throughout all settings of care and continue to harm an unacceptable number of patients. It is likely that most people will experience at least one diagnostic error in their lifetime, sometimes with devastating consequences. Diagnostic errors may cause harm to patients by preventing or delaying appropriate treatment, providing unnecessary or harmful treatment, or resulting in psychological or financial repercussions. The committee concluded that improving the diagnostic process is not only possible, but also represents a moral, professional, and public health imperative. Improving Diagnosis in Health Care, a continuation of the landmark Institute of Medicine reports To Err Is Human (2000) and Crossing the Quality Chasm (2001), finds that diagnosis-and, in particular, the occurrence of diagnostic errorsâ€has been largely unappreciated in efforts to improve the quality and safety of health care. Without a dedicated focus on improving diagnosis, diagnostic errors will likely worsen as the delivery of health care and the diagnostic process continue to increase in complexity. Just as the diagnostic process is a collaborative activity, improving diagnosis will require collaboration and a widespread commitment to change among health care professionals, health care organizations, patients and their families, researchers, and policy makers. The recommendations of Improving Diagnosis in Health Care contribute to the growing momentum for change in this crucial area of health care quality and safety. |
| gap analysis medical device: Clinical Evaluation and Investigation of Medical Devices under the new EU-Regulation Wolfgang Ecker, Gerold Labek, Tarquin Mittermayr, Brigitte Raffeiner, Michael Ring, Bernhard Schwartz, 2020-06-04 The concept of clinical evaluation and the framework for clinical investigations have been significantly enforced within the new EU-Medical Device Regulation (MDR). This book provides in-depth and practice-oriented guidance on the systematic identification and generation of clinical data through clinical investigations and other relevant sources. It addresses the needs of all stakeholders, be it manufacturers, notified bodies or competent authorities, when they have to plan, perform or assess clinical evaluations and investigations for medical devices on the way to conformity assessment and CE marking. It is a valuable tool of qualification for clinicians and related experts when preparing for a role of a clinical evaluator in the field, either when serving any of the stakeholders or when trying to make their own involvement stand out in start-ups. spin-offs or other development projects or in counselling services. |
| gap analysis medical device: 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. |
| gap analysis medical device: Medical Devices and IVDs Wolfgang Ecker, 2022-03-25 With this book, you get a really complete seminar for the new Regulations on medical devices and IVDs in the EU, ready at hand, at any time. These EU regulations create new rules for medical technology and laboratory diagnostics in Europe. Concise regulatory know-how is now required to keep or reposition medical devices and in vitro diagnostics on the European market, from syringes, contact lenses, medical device apps, pregnancy tests, nuclear magnetic resonance tomography to cancer tests, genetic diagnostics, HIV tests, hip implants, heart catheters, artificial spinal discs, stents and pacemakers. Concise regulatory training and further education of employees in companies and health care facilities is the order of the day. This also applies to biomedical and medical technology students at universities of applied sciences and biomedical universities, start-ups and spin-offs, who must make use of this know-how from the initial product idea through the further stages of product development to market access. The book provides a thorough, compact course on the new regulations, starting with perfect overview and easy navigation and going into depth where you need it: this book will make you fit and confident for the new European challenges! 344 pages; 47 col. figures; 26 tables |
| gap analysis medical device: WHO Global Model Regulatory Framework for Medical Devices Including in Vitro Diagnostic Medical Devices World Health Organization, 2017-05-09 The Model recommends guiding principles and harmonized definitions and specifies the attributes of effective and efficient regulation to be embodied within binding and enforceable law. Its main elements refer to international harmonization guidance documents developed by the Global Harmonization Task Force (GHTF) and its successor, the International Medical Device Regulators Forum (IMDRF). The Model is particularly relevant for WHO Member States with little or no regulation for medical devices currently in place but with the ambition to improve this situation. It foresees that such countries will progress from basic regulatory controls towards an expanded level to the extent that their resources allow. The Model is written for the legislative, executive, and regulatory branches of government as they develop and establish a system of medical devices regulation. It describes the role and responsibilities of a country's regulatory authority for implementing and enforcing the regulations. Also, it describes circumstances in which a regulatory authority may either rely on or recognize the work products from trusted regulatory sources (such as scientific assessments, audit, and inspection reports) or from the WHO Prequalification Team. Section 2 of this document recommends definitions of the terms medical devices and IVDs. It describes how they may be grouped according to their potential for harm to the patient or user and specifies principles of safety and performance that the device manufacturer must adhere to. It explains how the manufacturer must demonstrate to a regulatory authority that its medical device has been designed and manufactured to be safe and to perform as intended during its lifetime. Section 3 presents the principles of good regulatory practice and enabling conditions for effectively regulating medical devices. It then introduces essential tools for regulation, explaining the function of the regulatory entity and the resources required. Section 4 presents a stepwise approach to implementing and enforcing regulatory controls for medical devices as the regulation progresses from a basic to an expanded level. It describes elements from which a country may choose according to national priorities and challenges. Also, it provides information on when the techniques of reliance and recognition may be considered and on the importance of international convergence of regulatory practice.Section 5 provides a list of additional topics to be considered when developing and implementing regulations for medical devices. It explains the relevance of these topics and provides guidance for regulatory authorities to ensure that they are addressed appropriately. The Model outlines a general approach but cannot provide country-specific guidance on implementation. While it does not offer detailed guidance on regulatory topics, it contains references to relevant documents where further information may be found. It does not detail the responsibilities of other stakeholders such as manufacturers, distributors, procurement agencies, and health-care professionals, all of whom have roles in assuring the quality, safety, and performance of medical devices. |
| gap analysis medical device: Contextual Inquiry for Medical Device Design Mary Beth Privitera, 2015-05-29 Contextual Inquiry for Medical Device Design helps users understand the everyday use of medical devices and the way their usage supports the development of better products and increased market acceptance. The text explains the concept of contextual inquiry using real-life examples to illustrate its application. Case studies provide a frame of reference on how contextual inquiry is successfully used during product design, ultimately producing safer, improved medical devices. - Presents the ways contextual inquiry can be used to inform the evaluation and business case of technology - Helps users understand the everyday use of medical devices and the way their usage supports the development of better products - Includes case studies that provide a frame of reference on how contextual inquiry is successfully used during the product design process |
| gap analysis medical device: Writing In-House Medical Device Software in Compliance with EU, UK, and US Regulations Philip S. Cosgriff, Matthew J. Memmott, 2024-03-26 This book is a comprehensive guide to producing medical software for routine clinical use. It is a practical guidebook for medical professionals developing software to ensure compliance with medical device regulations for software products intended to be sold commercially, shared with healthcare colleagues in other hospitals, or simply used in-house. It compares requirements and latest regulations in different global territories, including the most recent EU regulations as well as UK and US regulations. This book is a valuable resource for practising clinical scientists producing medical software in-house, in addition to other medical staff writing small apps for clinical use, clinical scientist trainees, and software engineers considering a move into healthcare. The academic level is post-graduate, as readers will require a basic knowledge of software engineering principles and practice. Key Features: Up to date with the latest regulations in the UK, the EU, and the US Useful for those producing medical software for routine clinical use Contains best practice |
| gap analysis medical device: Medical Devices and In Vitro Diagnostics Christian Baumgartner, Johann Harer, Jörg Schröttner, 2023-08-26 This updatable reference work gives a comprehensive overview of all relevant regulatory information and requirements for manufacturers and distributors around medical and in-vitro diagnostic devices in Europe. These individual requirements are presented in a practice-oriented manner, providing the reader with a concrete guide to implementation with main focus on the EU medical device regulations, such as MDR 2017/745 and IVD-R 2017/746, and the relevant standards, such as the ISO 13485, ISO 14971, among others. This book offers a good balance of expert knowledge, empirical values and practice-proven methods. Not only it provides readers with a quick overview about the most important requirements in the medical device sector, yet it shows concrete and proven ways in which these requirements can be implemented in practice. It addresses medical manufacturing companies, professionals in development, production, and quality assurance departments, and technical and medical students who are preparing themselves for a professional career in the medical technlogy industries. |
| gap analysis medical device: 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. |
| gap analysis medical device: Innovation and Invention in Medical Devices Institute of Medicine, Board on Health Sciences Policy, Roundtable on Research and Development of Drugs, Biologics, and Medical Devices, 2001-12-01 The objective of the workshop that is the subject of this summary report was to present the challenges and opportunities for medical devices as perceived by the key stakeholders in the field. The agenda, and hence the summaries of the presentations that were made in the workshop and which are presented in this summary report, was organized to first examine the nature of innovation in the field and the social and economic infrastructure that supports such innovation. The next objective was to identify and discuss the greatest unmet clinical needs, with a futuristic view of technologies that might meet those needs. And finally, consideration was given to the barriers to the application of new technologies to meet clinical needs. |
| gap analysis medical device: Resilient Health Care Professor Robert L Wears, Professor Erik Hollnagel, Professor Jeffrey Braithwaite, 2015-09-28 Properly performing health care systems require concepts and methods that match their complexity. Resilience engineering provides that capability. It focuses on a system’s overall ability to sustain required operations under both expected and unexpected conditions rather than on individual features or qualities. This book contains contributions from international experts in health care, organisational studies and patient safety, as well as resilience engineering. Whereas current safety approaches primarily aim to reduce the number of things that go wrong, Resilient Health Care aims to increase the number of things that go right. |
| gap analysis medical device: Biocompatibility and Performance of Medical Devices Jean-Pierre Boutrand, 2019-11-21 Biocompatibility and Performance of Medical Devices, Second Edition, provides an understanding of the biocompatibility and performance tests for ensuring that biomaterials and medical devices are safe and will perform as expected in the biological environment. Sections cover key concepts and challenges faced in relation to biocompatibility in medical devices, discuss the evaluation and characterization of biocompatibility in medical devices, describe preclinical performance studies for bone, dental and soft tissue implants, and provide information on the regulation of medical devices in the European Union, Japan and China. The book concludes with a review of histopathology principles for biocompatibility and performance studies. - Presents diverse insights from experts in government, industry and academia - Delivers a comprehensive overview of testing and interpreting medical device performance - Expanded to include new information, including sections on managing extractables, accelerating and simplifying medical device development through screening and alternative biocompatibility methods, and quality strategies which fasten device access to market |
| gap analysis medical device: Medical Equipment Maintenance Binseng Wang, 2022-05-31 In addition to being essential for safe and effective patient care, medical equipment also has significant impact on the income and, thus, vitality of healthcare organizations. For this reason, its maintenance and management requires careful supervision by healthcare administrators, many of whom may not have the technical background to understand all of the relevant factors. This book presents the basic elements of medical equipment maintenance and management required of healthcare leaders responsible for managing or overseeing this function. It will enable these individuals to understand their professional responsibilities, as well as what they should expect from their supervised staff and how to measure and benchmark staff performance against equivalent performance levels at similar organizations. The book opens with a foundational summary of the laws, regulations, codes, and standards that are applicable to the maintenance and management of medical equipment in healthcare organizations. Next, the core functions of the team responsible for maintenance and management are described in sufficient detail for managers and overseers. Then the methods and measures for determining the effectiveness and efficiency of equipment maintenance and management are presented to allow performance management and benchmarking comparisons. The challenges and opportunities of managing healthcare organizations of different sizes, acuity levels, and geographical locations are discussed. Extensive bibliographic sources and material for further study are provided to assist students and healthcare leaders interested in acquiring more detailed knowledge. Table of Contents: Introduction / Regulatory Framework / Core Functions of Medical Equipment Maintenance and Management / CE Department Management / Performance Management / Discussion and Conclusions |
| gap analysis medical device: Biocompatibility Protocols for Medical Devices and Materials Prakash Srinivasan Timiri Shanmugam, Thamizharasan Sampath, Indumathy Jagadeeswaran, 2023-04-07 Biocompatibility Protocols for Medical Devices and Materials provides comprehensive coverage of the basic science and toxicological testing protocols necessary for the risk assessment and safety analysis of medical devices and materials which are based on the ISO guidelines for body contact and duration of contact. The book begins with device/component selection for toxicological experiments and provides an introduction to topics such as sensitization, irritation tests, material-mediated pyrogenicity, and bacterial-mediated pyrogenicity. Toxicology-related chapters explain the protocols for cytotoxicity, acute systemic toxicity, repeated-exposure systemic toxicity, genotoxicity, carcinogenicity, and reproductive toxicity testing. Biocompatibility Protocols for Medical Devices and Materials is a practical guide that provides step-by-step toxicological protocols ranging from materials selection to data interpretation for toxicologists, biomedical researchers, healthcare professionals, product developers, and others working in risk assessment and safety analysis of medical devices. - Explains the biocompatibility test protocols for medical devices - Provides an overview about chemical characterization - Describes toxicokinetic, carcinogenicity, and reproductive toxicity studies - Discusses the basic points needed to leverage the data from another device |
| gap analysis medical device: WHO Expert Committee on Biological Standardization World Health Organization, 2023-05-26 The 76th meeting of the WHO Expert Committee on Biological Standardization was held from 24 to 28 October 2023 by Zoom video conferencing. The meeting was opened on behalf of the Director-General of WHO by Dr Clive Ondari, Director, Health Products Policy and Standards. The Expert Committee on Biological Standardization reviews developments in the field of biological substances used in human medicine, which include vaccines, biotherapeutics, blood products and related substances, and in vitro diagnostic reagents. It coordinates activities leading to: (a) the adoption of WHO guidelines and recommendations for assuring the quality, safety and efficacy of such substances; and (b) the establishment of WHO international standards and other reference materials. The use of international reference materials for designating the activity of biological substances used in prophylaxis or therapy, or for ensuring the reliability of quality control or diagnostic procedures, allows for the comparison of data worldwide. Target audience includes - but is not limited to - regulators, manufacturers, policymakers, health workers, developers of vaccines and other biological products and academia. |
| gap analysis medical device: Planning, Writing and Reviewing Medical Device Clinical and Performance Evaluation Reports (CERs/PERs) Joy Frestedt, 2024-09-27 A Practical Guide to Planning, Writing, and Reviewing Medical Device Clinical Evaluation Reports guides readers through clinical data evaluation of medical devices, in compliance with the EU MDR requirements and other similar regulatory requirements throughout the world. This book brings together knowledge learned as the author constructed hundreds of CERs and taught thousands of learners on how to conduct clinical data evaluations. This book will support training for clinical engineers, clinical evaluation scientists, and experts reviewing medical device CERs, and will help individual writers, teams and companies to develop stronger, more robust CERs. Identifies and explains data analysis for clinical evaluation of medical devices Teaches readers how to understand and evaluate medical device performance and safety in the context of new regulations Provides analysis of new clinical evaluation criteria in the context of medical device design as well as in-hospital deployment and servicing |
| gap analysis medical device: Artificial Intelligence in Healthcare Adam Bohr, Kaveh Memarzadeh, 2020-06-21 Artificial Intelligence (AI) in Healthcare is more than a comprehensive introduction to artificial intelligence as a tool in the generation and analysis of healthcare data. The book is split into two sections where the first section describes the current healthcare challenges and the rise of AI in this arena. The ten following chapters are written by specialists in each area, covering the whole healthcare ecosystem. First, the AI applications in drug design and drug development are presented followed by its applications in the field of cancer diagnostics, treatment and medical imaging. Subsequently, the application of AI in medical devices and surgery are covered as well as remote patient monitoring. Finally, the book dives into the topics of security, privacy, information sharing, health insurances and legal aspects of AI in healthcare. - Highlights different data techniques in healthcare data analysis, including machine learning and data mining - Illustrates different applications and challenges across the design, implementation and management of intelligent systems and healthcare data networks - Includes applications and case studies across all areas of AI in healthcare data |
| gap analysis medical device: 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 |
| gap analysis medical device: 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 |
| gap analysis medical device: Moving Towards Everlasting Artificial Intelligent Battery-Powered Implants Marvellous Moyo, Tawanda Mushiri, 2024-10-15 Moving Towards Everlasting Artificial Intelligent Battery-Powered Implants presents the development process of new artificial intelligent (AI) charging systems for battery-powered implants that can last for a lifetime after implantation. This book introduces new strategies to address the limitations of technologies that have been employed to improve the lifespan of medical implants. This book also provides guidelines that medical implant manufacturers can adopt during their product development stages—this adds a new dimension of research on medical device implants that can be a game changer for the AI medical implants industry. Researchers, engineers, and graduate students in the elds of biomedical engineering, electrical engineering, and computer science will find this text helpful as they seek to understand the potential of AI systems to help achieve sustainability in healthcare and make current medical implants relevant in the future. - Presents basic and advanced concepts in medical implants design - Explores various uses of AI and engineering concepts in optimization and enhancement of medical devices - Facilitates new approaches in improving patient safety and reliability of medical devices |
| gap analysis medical device: Health Care Comes Home National Research Council, Division of Behavioral and Social Sciences and Education, Board on Human-Systems Integration, Committee on the Role of Human Factors in Home Health Care, 2011-06-22 In the United States, health care devices, technologies, and practices are rapidly moving into the home. The factors driving this migration include the costs of health care, the growing numbers of older adults, the increasing prevalence of chronic conditions and diseases and improved survival rates for people with those conditions and diseases, and a wide range of technological innovations. The health care that results varies considerably in its safety, effectiveness, and efficiency, as well as in its quality and cost. Health Care Comes Home reviews the state of current knowledge and practice about many aspects of health care in residential settings and explores the short- and long-term effects of emerging trends and technologies. By evaluating existing systems, the book identifies design problems and imbalances between technological system demands and the capabilities of users. Health Care Comes Home recommends critical steps to improve health care in the home. The book's recommendations cover the regulation of health care technologies, proper training and preparation for people who provide in-home care, and how existing housing can be modified and new accessible housing can be better designed for residential health care. The book also identifies knowledge gaps in the field and how these can be addressed through research and development initiatives. Health Care Comes Home lays the foundation for the integration of human health factors with the design and implementation of home health care devices, technologies, and practices. The book describes ways in which the Agency for Healthcare Research and Quality (AHRQ), the U.S. Food and Drug Administration (FDA), and federal housing agencies can collaborate to improve the quality of health care at home. It is also a valuable resource for residential health care providers and caregivers. |
| gap analysis medical device: Handbook of Research on Advances in Digital Technologies to Promote Rehabilitation and Community Participation Simões de Almeida, Raquel, Simões-Silva, Vítor, Trigueiro, Maria João, 2023-12-07 Digital technologies hold immense potential to transform the field of rehabilitation and enable greater community participation for individuals with disabilities. In the Handbook of Research on Advances in Digital Technologies to Promote Rehabilitation and Community Participation, a comprehensive exploration of these cutting-edge technologies and their impact is presented, and it delves into various digital solutions, such as virtual reality, tele-rehabilitation, mobile apps, rehabilitation platforms, and more. The book sheds light on the applications to promote rehabilitation and enhance community involvement. It provides a profound understanding of how these technologies can facilitate remote rehabilitation, foster self-management of illnesses, support independent living, and enhance communication and social participation. Furthermore, it emphasizes the accessibility of information and resources that digital technologies provide, unlocking new possibilities for individuals with disabilities. However, this research goes beyond mere exploration and also examines the challenges and opportunities associated with these digital advancements. The ethical considerations that arise in the utilization of these technologies are addressed, emphasizing the need for responsible and considerate implementation. |
| gap analysis medical device: Medical Device Epidemiology and Surveillance S. Lori Brown, Roselie A. Bright, Dale R. Tavris, 2007-03-13 Medical devices are crucial in medical care today and device technology advances at a dizzying pace. Medical Device Epidemiology and Surveillance is the first book to provide an overview of medical device epidemiology and surveillance as well as perspectives from regulatory agencies, the medical device industry, the health insurance industry and academia. The book is edited by experts from the US Food and Drug Administration with contributions from experienced specialists working in this field in the US and around the world. It features chapters describing broad themes in medical device epidemiology and surveillance, as well as chapters that describe specific medical devices. Medical Device Epidemiology and Surveillance is an essential reference for epidemiologists, pharmacoepidemiologists, academics, graduate students, and everybody working in the medical device industry. |
| gap analysis medical device: WHO Expert Committee on Specifications for Pharmaceutical Preparations World Health Organization, 2022-12-22 |
| gap analysis medical device: Quality assurance of pharmaceuticals: a compendium of guidelines and related materials. Volume 2. Good manufacturing practices and inspection World Health Organization, 2024-01-31 The GMP Compendium for Medical Products is a valuable resource for manufacturers, regulators, and other stakeholders involved in producing and distributing medical products. It covers various topics, from quality management systems to personnel hygiene, equipment validation, and complaint handling. The guidance provided is based on the latest scientific and technical knowledge and considers the evolving regulatory landscape and the challenges faced by the industry. |
| gap analysis medical device: Health Security Intelligence Michael S. Goodman, James M. Wilson, Filippa Lentzos, 2021-12-19 Health Security Intelligence introduces readers to the world of health security, to threats like COVID-19, and to the many other incarnations of global health security threats and their implications for intelligence and national security. Disease outbreaks like COVID-19 have not historically been considered a national security matter. While disease outbreaks among troops have always been a concern, it was the potential that arose in the first half of the twentieth century to systematically design biological weapons and to develop these at an industrial scale, that initially drew the attention of security, defence and intelligence communities to biology and medical science. This book charts the evolution of public health and biosecurity threats from those early days, tracing how perceptions of these threats have expanded from deliberately introduced disease outbreaks to also incorporate natural disease outbreaks, the unintended consequences of research, laboratory accidents, and the convergence of emerging technologies. This spectrum of threats has led to an expansion of the stakeholders, tools and sources involved in intelligence gathering and threat assessments. This edited volume is a landmark in efforts to develop a multidisciplinary, empirically informed, and policy-relevant approach to intelligence-academia engagement in global health security that serves both the intelligence community and scholars from a broad range of disciplines. The chapters in this book were originally published as a special issue of the journal, Intelligence and National Security. |
| gap analysis medical device: Computer Safety, Reliability, and Security Andrea Bondavalli, Felicita Di Giandomenico, 2014-09-03 This book constitutes the refereed proceedings of the 33nd International Conference on Computer Safety, Reliability, and Security, SAFECOMP 2014, held in Florence, Italy, in September 2014. The 20 revised full papers presented together with 3 practical experience reports were carefully reviewed and selected from 85 submissions. The papers are organized in topical sections on fault injection techniques, verification and validation techniques, automotive systems, coverage models and mitigation techniques, assurance cases and arguments, system analysis, security and trust, notations/languages for safety related aspects, safety and security. |
| gap analysis medical device: Software Process Improvement and Capability Determination Tanja Woronowicz, Terry Rout, Rory V. O’Connor, Alec Dorling, 2013-05-21 This book constitutes the refereed proceedings of the 13th International Conference on Software Process Improvement and Capability Determination, SPICE 2013, held in Bremen, Germany, in June 2013. The 21 revised full papers presented and 7 short papers were carefully reviewed and selected from numerous submissions. The papers are organized in topical sections on process quality; medical device software processes; design and use of process models; studies of software development; agile development; IT service management; assessment for diagnosis. |
| gap analysis medical device: Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics Carmen Medina, 2003-12-09 This text lists the necessary steps for meeting compliance requirements during the drug development process. It presents comprehensive approaches for validating analytical methods for pharmaceutical applications. |
| gap analysis medical device: Acute and Chronic Wounds Ruth Bryant, Denise Nix, 2015-11-24 Prevent and manage wounds with this expert, all-inclusive resource! Acute & Chronic Wounds: Current Management Concepts, 5th Edition provides the latest diagnostic and treatment guidelines to help you provide quality care for patients with wounds. This textbook presents an interprofessional approach to maintaining skin integrity and managing the numerous types of skin damage including topics that range from the physiology of wound healing, general principles of wound management, vulnerable patient populations, management of percutaneous tubes, and specific care instructions to program development. Written by respected nursing educators Ruth Bryant and Denise Nix, this bestselling reference also provides excellent preparation for all wound certification exams. A comprehensive approach to the care of patients with acute and chronic wounds guides students and health care providers to design, deliver and evaluate quality skin and wound care in a systematic fashion; the comprehensive approach includes the latest advances in diagnosis, differentiation of wound types, nutrition, prevention, treatment, and pharmacology. Self-assessment questions and answers in each chapter help you assess your knowledge and prepare for all wound certification exams. Checklists offer a concise, easy-to-read summary of the steps needed to achieve the best patient care outcomes. Risk assessment scales help in determining a patient's risk for developing a wound, and wound classification tools identify the proper terminology to be used in documentation. Learning objectives at the beginning of each chapter focus your study on the most important content. Principles for practice development boost outcomes and productivity in agencies and institutions, home care, acute care, long-term care, and long-term acute care settings. NEW coverage includes the latest guidelines from WOCN, AAWC, NPUAP, EPUAP, and PPPIA, and the American College of Physicians. New sections cover the prevention and management of biofilm, the new skin tear classification system, MASD and MARCI, CTP terminology and classification scheme, and integration of the Health Belief Model. NEW! Additional full-color photographs show the differential diagnosis of types of skin damage, management of fistulas, and NPWT procedures. NEW! Clinical Consult features help in applying concepts to clinical practice, showing students and health care professionals how to assess, manage, and document real-life patient and staff encounters using the ADPIE framework. NEW two-color illustrations and design make the book more visually appealing. |
| gap analysis medical device: Acute and Chronic Wounds - E-Book Ruth Bryant, Denise Nix, 2015-12-07 Prevent and manage wounds with this expert, all-inclusive resource! Acute & Chronic Wounds: Current Management Concepts, 5th Edition provides the latest diagnostic and treatment guidelines to help you provide quality care for patients with wounds. This textbook presents an interprofessional approach to maintaining skin integrity and managing the numerous types of skin damage including topics that range from the physiology of wound healing, general principles of wound management, vulnerable patient populations, management of percutaneous tubes, and specific care instructions to program development. Written by respected nursing educators Ruth Bryant and Denise Nix, this bestselling reference also provides excellent preparation for all wound certification exams. - A comprehensive approach to the care of patients with acute and chronic wounds guides students and health care providers to design, deliver and evaluate quality skin and wound care in a systematic fashion; the comprehensive approach includes the latest advances in diagnosis, differentiation of wound types, nutrition, prevention, treatment, and pharmacology. - Self-assessment questions and answers in each chapter help you assess your knowledge and prepare for all wound certification exams. - Checklists offer a concise, easy-to-read summary of the steps needed to achieve the best patient care outcomes. - Risk assessment scales help in determining a patient's risk for developing a wound, and wound classification tools identify the proper terminology to be used in documentation. - Learning objectives at the beginning of each chapter focus your study on the most important content. - Principles for practice development boost outcomes and productivity in agencies and institutions, home care, acute care, long-term care, and long-term acute care settings. - NEW coverage includes the latest guidelines from WOCN, AAWC, NPUAP, EPUAP, and PPPIA, and the American College of Physicians. - New sections cover the prevention and management of biofilm, the new skin tear classification system, MASD and MARCI, CTP terminology and classification scheme, and integration of the Health Belief Model. - NEW! Additional full-color photographs show the differential diagnosis of types of skin damage, management of fistulas, and NPWT procedures. - NEW! Clinical Consult features help in applying concepts to clinical practice, showing students and health care professionals how to assess, manage, and document real-life patient and staff encounters using the ADPIE framework. - NEW two-color illustrations and design make the book more visually appealing. |
| gap analysis medical device: Advances in Production Management Systems. Production Management Systems for Volatile, Uncertain, Complex, and Ambiguous Environments Matthias Thürer, |
| gap analysis medical device: Pharmaceutical Computer Systems Validation Guy Wingate, 2016-04-19 Thoroughly revised to include the latest industry developments, the Second Edition presents a comprehensive overview of computer validation and verification principles and how to put them into practice. To provide the current best practice and guidance on identifying and implementing improvements for computer systems, the text extensively reviews regulations of pharmaceuticals, healthcare products, blood processing, medical devices, clinical systems, and biotechnology. Ensuring that organizations transition smoothly to the new system, this guide explains how to implement the new GMP paradigm while maintaining continuity with current practices. In addition, all 24 case studies from the previous edition have been revised to reflect the new system. |
| gap analysis medical device: The Benchmarks Sourcebook: Four Decades of Related Research Jean Brittain Leslie, Michael John Peterson, John W. Fleenor, 2023-03-22 Benchmarks, a 360-degree assessment, has been used by approximately 21,000 organizations and over 265,500 managers. Data collected through its administration have resulted in large comprehensive databases that have provided the basis for numerous studies. These annotations on published research were written for anyone who is interested in the research leading to the development and refinement of Benchmarks, the interpretation of the assessment’s results, or the relationship of Benchmarks to other psychological assessments. |
| gap analysis medical device: Improving Healthcare Quality in Europe Characteristics, Effectiveness and Implementation of Different Strategies OECD, World Health Organization, 2019-10-17 This volume, developed by the Observatory together with OECD, provides an overall conceptual framework for understanding and applying strategies aimed at improving quality of care. Crucially, it summarizes available evidence on different quality strategies and provides recommendations for their implementation. This book is intended to help policy-makers to understand concepts of quality and to support them to evaluate single strategies and combinations of strategies. |
| gap analysis medical device: Medical-Grade Software Development Ilkka Juuso, Ilpo Pöyhönen, 2023-11-13 This book is a practical guide to meeting IEC 62304 software-development requirements within the context of an ISO 13485 quality management system (QMS). The book proves this can be done with a minimum amount of friction, overlap, and back-and-forth between development stages. It essentially shows you how you should shape your medical-software development processes to fit in with the QMS processes in the smartest and leanest way possible. By following the advice in this book, you can reuse processes from your QMS, ensure your product-realization processes meet the requirements for medical-software development, and marry all the requirements together using tried and tested solutions into one efficient system. The expertise of the authors here goes beyond just the experiences of one real-world project as they tap into over 30 years of experience and countless software and software-assessment projects to distill their advice. The book takes a hands-on approach by first teaching you the top 25 lessons to know before starting to develop a process for medical-software development. It then walks you through the expectations placed on the key aspects of such a process by the key standards. The book progresses from an overview of both standards and the general requirements involved to a detailed discussion of the expected stages from software development and maintenance to risk management, configuration management, and problem resolution. The book provides insightful advice on how the requirements of the IEC 62304 software-development life cycle can be married with an ISO 13485 QMS, how the development of the technical file should be organized, and how to address conformity assessment, the daily after-approval, and the recent trends that will affect the industry in the coming years. The book is modeled after the IEC 62304 standard and adopts its clause structure in the numbering of sections for easy reference. The book does not attempt to replicate either standard. For the ISO 13485 standard, it recites the necessary requirements succinctly. For IEC 62304, the discussion is in-depth and also addresses the impact of ISO 13485 on the requirements discussed. In this way, the book drills into both standards to expose the core of each requirement and shape these into a practical, cohesive workflow for developing, maintaining, and improving a Lean software development pipeline. |
| gap analysis medical device: Safety Risk Management for Medical Devices Bijan Elahi, 2021-11-11 Safety Risk Management for Medical Devices, Second Edition teaches the essential safety risk management methodologies for medical devices compliant with the requirements of ISO 14971:2019. Focusing exclusively on safety risk assessment practices required in the MedTech sector, the book outlines sensible, easily comprehensible, state-of the-art methodologies that are rooted in current industry best practices, addressing safety risk management of medical devices, thus making it useful for those in the MedTech sector who are responsible for safety risk management or need to understand risk management, including design engineers, product engineers, development engineers, software engineers, Quality assurance and regulatory affairs. Graduate-level engineering students with an interest in medical devices will also benefit from this book. The new edition has been fully updated to reflect the state-of-the-art in this fast changing field. It offers guidance on developing and commercializing medical devices in line with the most current international standards and regulations. - Includes new coverage of ISO 14971:2019, ISO/TR 24971 - Presents the latest information on the history of risk management, lifetime of a medical device, risk management review, production and post production activities, post market risk management - Provides practical, easy-to-understand and state-of the-art methodologies that meet the requirements of international regulation |
Stihl Ignition Module Air Gap... - Arborist, Chainsaw & Tree Work …
Jun 12, 2005 · Next, the shop manual says to remove the setting gage, and measure the resulting air gap which is 0.008" - 0.012". Sounds easy enough. Here's the problem, the stihl setting …
AC Delco R45TS gap out of the box - Team Chevelle
Apr 12, 2018 · Test engine was a 253 Cu in V6. Stock ign, 045 plug gap, it made 168 hp. With Platinum plugs, same 045 gap, it made 171 hp. Split Fire plugs, same 171 HP. With surface …
BBC Intakes ---AFR 4910 vs Edelbrock RPM Air Gap
Nov 11, 2024 · I decided to a buy the AFR 4910 intake for my 502BBC with 265 AFR heads. AFR advertises the 4910 as the ultimate out of box match for their oval heads. For the record here …
torque converter/flexplate gap - Team Camaro Tech
Sep 27, 2015 · feeler gauges or calipers measure the gap between the flexplate converter mounting pad and the torque converter mounting pad. If gap distan ce is between .060” and …
Piston ring gap - Team Chevelle
Apr 16, 2023 · Rule of thumb for a naturally aspirated engine 0.004" gap per inch of bore so in your case you should shoot for 0.016-0.017" (4.155 x 0.004) ideally. If your gap is 0.032" you …
Real world HEI spark plug gaps - Team Chevelle
Aug 12, 2017 · If yu still see a specification for an incorrect giant spark plug gap for an HEi for any of the HEI's, DROP THE GAP DOWN TO THE PROPER SPECIFICATION OF .045 …
Starter too far from flexplate-what to do? - Team Chevelle
Jun 4, 2010 · Shimming only the outer side of the starter will draw it closer to the flexplate. Also, some starters have a smaller diameter pinion shaft (but the gear itself is the same size). If …
Spark plug and gap for higher compression BBC | Team Chevelle
Aug 24, 2017 · Go with a colder plug for higher compression and experiment from there. Depends a lot on how high the compression is and altitude, etc. Stick with the recommended plug gap …
Spark Plug Gap on 454 - Team Chevelle
Jan 30, 2006 · Can anyone tell me what the spark plug gap on a 454 should be. I changed the plugs on my 454 and it seems as if it is missing a little at low RPM. Does anyone recommed a …
Spark plug gap & Pertronix Ignitor - Team Chevelle
Jul 22, 2019 · The wider the gap the higher the spark voltage and current is needed because it takes higher voltage to cross a wider gap. That also allows the coil to charge more. Just basic …
Stihl Ignition Module Air Gap... - Arborist, Chainsaw & Tree Work …
Jun 12, 2005 · Next, the shop manual says to remove the setting gage, and measure the resulting air gap which is 0.008" - 0.012". Sounds easy enough. Here's the problem, the stihl setting …
AC Delco R45TS gap out of the box - Team Chevelle
Apr 12, 2018 · Test engine was a 253 Cu in V6. Stock ign, 045 plug gap, it made 168 hp. With Platinum plugs, same 045 gap, it made 171 hp. Split Fire plugs, same 171 HP. With surface …
BBC Intakes ---AFR 4910 vs Edelbrock RPM Air Gap
Nov 11, 2024 · I decided to a buy the AFR 4910 intake for my 502BBC with 265 AFR heads. AFR advertises the 4910 as the ultimate out of box match for their oval heads. For the record here …
torque converter/flexplate gap - Team Camaro Tech
Sep 27, 2015 · feeler gauges or calipers measure the gap between the flexplate converter mounting pad and the torque converter mounting pad. If gap distan ce is between .060” and …
Piston ring gap - Team Chevelle
Apr 16, 2023 · Rule of thumb for a naturally aspirated engine 0.004" gap per inch of bore so in your case you should shoot for 0.016-0.017" (4.155 x 0.004) ideally. If your gap is 0.032" you …
Real world HEI spark plug gaps - Team Chevelle
Aug 12, 2017 · If yu still see a specification for an incorrect giant spark plug gap for an HEi for any of the HEI's, DROP THE GAP DOWN TO THE PROPER SPECIFICATION OF .045 …
Starter too far from flexplate-what to do? - Team Chevelle
Jun 4, 2010 · Shimming only the outer side of the starter will draw it closer to the flexplate. Also, some starters have a smaller diameter pinion shaft (but the gear itself is the same size). If …
Spark plug and gap for higher compression BBC | Team Chevelle
Aug 24, 2017 · Go with a colder plug for higher compression and experiment from there. Depends a lot on how high the compression is and altitude, etc. Stick with the recommended plug gap …
Spark Plug Gap on 454 - Team Chevelle
Jan 30, 2006 · Can anyone tell me what the spark plug gap on a 454 should be. I changed the plugs on my 454 and it seems as if it is missing a little at low RPM. Does anyone recommed a …
Spark plug gap & Pertronix Ignitor - Team Chevelle
Jul 22, 2019 · The wider the gap the higher the spark voltage and current is needed because it takes higher voltage to cross a wider gap. That also allows the coil to charge more. Just basic …
