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Risk Management For The Medical Device Industry
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Book Synopsis RISK MANAGEMENT FOR THE MEDICAL DEVICE INDUSTRY by : Dr. Akash Sharma, Ms. Vriti Gamta , Mr. Gaurav Luthra
Download or read book RISK MANAGEMENT FOR THE MEDICAL DEVICE INDUSTRY written by Dr. Akash Sharma, Ms. Vriti Gamta , Mr. Gaurav Luthra and published by Notion Press. This book was released on 2023-07-25 with total page 139 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Risk Management for the Medical Device Industry: A Guide based on ISO 14971" is an essential resource for professionals in the fast-paced medical device industry. Authored by Dr. Akash Sharma, Ms. Vriti Gamta, and Mr. Gaurav Luthra, experts in regulatory affairs and quality management systems, this practical guide offers comprehensive insights into risk management and compliance. Covering the entire risk management lifecycle, it includes case studies, best practices, and practical examples, along with discussions on integrating risk management with quality management systems and emerging technologies. Equip yourself with the knowledge and tools to ensure safety and effectiveness in the global market.
Book Synopsis Safety Risk Management for Medical Devices by : Bijan Elahi
Download or read book Safety Risk Management for Medical Devices written by Bijan Elahi and published by Academic Press. This book was released on 2021-11-11 with total page 541 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Author :United States. Food and Drug Administration. Task Force on Risk Management Publisher : ISBN 13 : Total Pages :24 pages Book Rating :4.:/5 (319 download)
Book Synopsis Managing the Risks from Medical Product Use by : United States. Food and Drug Administration. Task Force on Risk Management
Download or read book Managing the Risks from Medical Product Use written by United States. Food and Drug Administration. Task Force on Risk Management and published by . This book was released on 1999 with total page 24 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Risk Management of Medical Devices for Healthcare Organisations by : James Mccaley
Download or read book Risk Management of Medical Devices for Healthcare Organisations written by James Mccaley and published by Academic Press. This book was released on 2016-06-01 with total page 250 pages. Available in PDF, EPUB and Kindle. Book excerpt: Covers designing and structuring a surveillance system to monitor medical devices Reviews current and future techniques to oversee, track, and assess medical devices within a healthcare organization Covers designing and structuring a surveillance system to monitor medical devices in order to help you comply with reforms on post market device surveillance Discusses all aspects of risk management in medical device development from ideation to application Risk Management of Medical Devices for Healthcare Organizations will help you identify what risks exist with medical devices in the context of a healthcare organization. The contents include coverage of how firms currently manage such risks (active vs. passive device surveillance), the strengths and limitations of those methods and what new directions the industry is heading to in order to optimize risk management. James McCauley has developed this book with a global audience in mind, and has prepared a comprehensive table of contents covering all aspects of risk management. This book is ideal for anyone at management level who needs to implement a risk management system for medical devices within a healthcare organization. McCauley includes information about automated reporting and analysis systems such as FAERS and DELTA systems, plus coverage of the medical device identification system US UDI. If you are researching and developing methods to survey and assess medical device safety and performance, this book will help you to generate a sound foundation in current methods for risk management of medical devices to pioneer new research. For clinical engineers, this book will help you to prevent and resolve equipment failure and any potential complications. About the author James McCauley Manager, Clinical Technology Services, Central Coast Local Health District Biomedical Engineer at Open Heart International Managing Director, M Engineering Australia Pty Ltd, trading as James McCauley & Associates
James McCauley has over 30 years of experience working in healthcare and biomedical engineering, specifically with a clinical engineering focus. At Open Heart International he supports open heart surgical teams on outreach missions and other medical specialties in developing countries. As a manager at Clinical Technology Services he is responsible for the implementation of Point of Care IVD’s, including evaluation and clinical assessment. He is also the current chairman for Biomedical Engineering Management Group NSW. James consultants for various commercial clients including Seventh Day Adventist Hospital, Medtek Pty Ltd, and the Commonwealth of Australia, represented by the Therapeutic Goods Administration. Until 2012 he was the Head of Biomedical Engineering at Royal Alexandra Hospital for Children, where he was responsible for research into and development of medical devices. He is currently the chair of the Biomedical Engineering Management Group NSW (BMEG) which represents the NSW Government, the NSW Public Health System and all 135 public hospitals in NSW.
Book Synopsis Quality Risk Management in the FDA-Regulated Industry by : José Rodríguez-Pérez
Download or read book Quality Risk Management in the FDA-Regulated Industry written by José Rodríguez-Pérez and published by Quality Press. This book was released on 2017-02-21 with total page 252 pages. Available in PDF, EPUB and Kindle. Book excerpt: The purpose of this new edition is to offer an updated view of the risk management field as it applies to medical products. Since the publication of the first edition (2012), the emphasis on risk-based processes has growth exponentially across all sectors, and risk management is now considered as significant as quality management. ISO 9001 was revised and now requires that top management promote the use of risk-based thinking. ISO 13485:2016, which specifies the requirements for a quality management system specific to the medical devices industry, also now shows a greater emphasis on risk management and risk-based decision making. In addition, the FDA Food Safety Modernization Act (FSMA) is the most important reform of U.S. food safety laws in more than 70 years. This indispensable book presents a systematic and comprehensive approach to quality risk management. It will assist medical and food product manufacturers with the integration of a risk management system or risk management principles and activities into their existing quality management system by providing practical explanations and examples. The appropriate use of quality risk management can facilitate compliance with regulatory requirements such as good manufacturing practice or good laboratory practice. All chapters have been updated and revised, and a new chapter has been added to discuss some of the most common pitfalls and misunderstandings regarding risk management, specifically those related to the use of FMEA as the only element of risk management programs. One of the appendices includes 12 case studies, and the companion CD-ROM contains dozens of U.S. FDA and European guidance documents as well as international harmonization documents (ICH and GHTF-IMDRF) related to risk management activities, as well as a 30-question exam (with answers) on the material discussed in the book.
Book Synopsis DESIGN CONTROLS, RISK MANAGEMENT & PROCESS VALIDATION FOR MEDICAL DEVICE PROFESSIONALS by : Vernon Geckler
Download or read book DESIGN CONTROLS, RISK MANAGEMENT & PROCESS VALIDATION FOR MEDICAL DEVICE PROFESSIONALS written by Vernon Geckler and published by Wasatch Consulting Resources LLC. This book was released on 2017-02-11 with total page 441 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis The Medical Device Industry by : John Burton
Download or read book The Medical Device Industry written by John Burton and published by Cambridge Scholars Publishing. This book was released on 2009-03-26 with total page 200 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Risk Management for the Medical Device Industry by : MS Vriti Gamta
Download or read book Risk Management for the Medical Device Industry written by MS Vriti Gamta and published by Notion Press. This book was released on 2023-07-03 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Risk Management for the Medical Device Industry: A Guide based on ISO 14971" is an essential resource for professionals in the fast-paced medical device industry. Authored by Dr. Akash Sharma, Ms. Vriti Gamta, and Mr. Gaurav Luthra, experts in regulatory affairs and quality management systems, this practical guide offers comprehensive insights into risk management and compliance. Covering the entire risk management lifecycle, it includes case studies, best practices, and practical examples, along with discussions on integrating risk management with quality management systems and emerging technologies. Equip yourself with the knowledge and tools to ensure safety and effectiveness in the global market.
Book Synopsis Design Controls for the Medical Device Industry by : Marie Teixeira
Download or read book Design Controls for the Medical Device Industry written by Marie Teixeira and published by CRC Press. This book was released on 2002-09-20 with total page 258 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Book Synopsis Managing Medical Devices within a Regulatory Framework by : Beth Ann Fiedler
Download or read book Managing Medical Devices within a Regulatory Framework written by Beth Ann Fiedler and published by Elsevier. This book was released on 2016-09-12 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Risk Management for Medical Device (MD/IVD) Manufacturers by : Joe Simon
Download or read book Risk Management for Medical Device (MD/IVD) Manufacturers written by Joe Simon and published by . This book was released on 2021-08 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis The Changing Economics of Medical Technology by : Institute of Medicine
Download or read book The Changing Economics of Medical Technology written by Institute of Medicine and published by National Academies Press. This book was released on 1991-02-01 with total page 225 pages. Available in PDF, EPUB and Kindle. Book excerpt: Americans praise medical technology for saving lives and improving health. Yet, new technology is often cited as a key factor in skyrocketing medical costs. This volume, second in the Medical Innovation at the Crossroads series, examines how economic incentives for innovation are changing and what that means for the future of health care. Up-to-date with a wide variety of examples and case studies, this book explores how payment, patent, and regulatory policiesâ€"as well as the involvement of numerous government agenciesâ€"affect the introduction and use of new pharmaceuticals, medical devices, and surgical procedures. The volume also includes detailed comparisons of policies and patterns of technological innovation in Western Europe and Japan. This fact-filled and practical book will be of interest to economists, policymakers, health administrators, health care practitioners, and the concerned public.
Book Synopsis Medical Device Regulations by : Michael Cheng
Download or read book Medical Device Regulations written by Michael Cheng and published by World Health Organization. This book was released on 2003-09-16 with total page 54 pages. Available in PDF, EPUB and Kindle. Book excerpt: The term 'medical devices' covers a wide range of equipment essential for patient care at every level of the health service, whether at the bedside, at a health clinic or in a large specialised hospital. Yet many countries lack access to high-quality devices, particularly in developing countries where health technology assessments are rare and there is a lack of regulatory controls to prevent the use of substandard devices. This publication provides a guidance framework for countries wishing to create or modify their own regulatory systems for medical devices, based on best practice experience in other countries. Issues highlighted include: the need for harmonised regulations; and the adoption, where appropriate, of device approvals of advanced regulatory systems to avoid an unnecessary drain on scarce resources. These approaches allow emphasis to be placed on locally-assessed needs, including vendor and device registration, training and surveillance and information exchange systems.
Book Synopsis Pharmaceutical Applications by : Ponnadurai Ramasami
Download or read book Pharmaceutical Applications written by Ponnadurai Ramasami and published by Walter de Gruyter GmbH & Co KG. This book was released on 2021-10-25 with total page 303 pages. Available in PDF, EPUB and Kindle. Book excerpt: Based on "The Virtual Conference on Chemistry and its Applications (VCCA-2020) - Research and Innovations in Chemical Sciences: Paving the Way Forward" held in August 2020 and organized by the Computational Chemistry Group of the University of Mauritius. The chapters reflect a wide range of fundamental and applied research in the chemical sciences and interdisciplinary subjects.
Book Synopsis Benefit-Risk Assessment Methods in Medical Product Development by : Qi Jiang
Download or read book Benefit-Risk Assessment Methods in Medical Product Development written by Qi Jiang and published by CRC Press. This book was released on 2017-12-19 with total page 296 pages. Available in PDF, EPUB and Kindle. Book excerpt: Guides You on the Development and Implementation of B–R Evaluations Benefit–Risk Assessment Methods in Medical Product Development: Bridging Qualitative and Quantitative Assessments provides general guidance and case studies to aid practitioners in selecting specific benefit–risk (B–R) frameworks and quantitative methods. Leading experts from industry, regulatory agencies, and academia present practical examples, lessons learned, and best practices that illustrate how to conduct structured B–R assessment in clinical development and regulatory submission. The first section of the book discusses the role of B–R assessments in medicine development and regulation, the need for both a common B–R framework and patient input into B–R decisions, and future directions. The second section focuses on legislative and regulatory policy initiatives as well as decisions made at the U.S. FDA’s Center for Devices and Radiological Health. The third section examines key elements of B–R evaluations in a product’s life cycle, such as uncertainty evaluation and quantification, quantifying patient B–R trade-off preferences, ways to identify subgroups with the best B–R profiles, and data sources used to assist B–R assessment. The fourth section equips practitioners with tools to conduct B–R evaluations, including assessment methodologies, a quantitative joint modeling and joint evaluation framework, and several visualization tools. The final section presents a rich collection of case studies. With top specialists sharing their in-depth knowledge, thought-provoking considerations, and practical advice, this book offers comprehensive coverage of B–R evaluation methods, tools, and case studies. It gives practitioners a much-needed toolkit to develop and conduct their own B–R evaluations.
Book Synopsis Medical Device Software Verification, Validation and Compliance by : David A. Vogel
Download or read book Medical Device Software Verification, Validation and Compliance written by David A. Vogel and published by Artech House. This book was released on 2011 with total page 445 pages. Available in PDF, EPUB and Kindle. Book excerpt: HereOCOs the first book written specifically to help medical device and software engineers, QA and compliance professionals, and corporate business managers better understand and implement critical verification and validation processes for medical device software.Offering you a much broader, higher-level picture than other books in this field, this book helps you think critically about software validation -- to build confidence in your softwareOCOs safety and effectiveness. The book presents validation activities for each phase of the development lifecycle and shows: why these activities are important and add value; how to undertake them; and what outputs need to be created to document the validation process.From software embedded within medical devices, to software that performs as a medical device itself, this comprehensive book explains how properly handled validation throughout the development lifecycle can help bring medical devices to completion sooner, at higher quality, in compliance with regulations."
Book Synopsis Risk-Based Quality Management in Healthcare Organization by : Dr. Akash Sharma, Ms. Vriti Gamta, Mr.Gaurav Luthra
Download or read book Risk-Based Quality Management in Healthcare Organization written by Dr. Akash Sharma, Ms. Vriti Gamta, Mr.Gaurav Luthra and published by Notion Press. This book was released on 2023-08-09 with total page 105 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Risk-Based Quality Management in Healthcare Organization: A Guide based on ISO 13485 and EU MDR" is a comprehensive handbook that offers practical guidance for healthcare professionals to excel in risk-based quality management. It explores the regulatory landscape of the healthcare industry, emphasizing ISO 13485 and EU MDR as the foundation. The book provides a step-by-step approach to implementing effective risk assessment and mitigation strategies, ensuring compliance with international standards. It includes best practices to navigate risk management throughout the medical device lifecycle. The guide also addresses integrating risk management into existing quality management systems, conducting audits, and meeting EU MDR requirements. By mastering the principles in this guide, professionals can enhance patient safety, improve product quality, and achieve regulatory compliance. It is a valuable resource for healthcare professionals involved in device design, manufacturing, testing, and regulatory affairs.
