Quality Risk Management in the FDA-Regulated Industry
Quality Risk Management in the FDA-Regulated Industry

Author: José Rodríguez Pérez

Publisher: Quality Press

Published: 2012-06-12

Total Pages: 289

ISBN-13: 0873898346

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Risk management principles are effectively utilized in many areas of business and government, including finance, insurance, occupational safety, and public health, and by agencies regulating these industries. The U.S. Food and Drug Administration (FDA) and its worldwide counterparts are responsible for protecting public health by ensuring the safety and effectiveness of the drugs and medical devices. Regulators must decide whether the benefits of a specific product for patients and users outweigh its risk, while recognizing that “absolute safety” (or zero risk) is not achievable. Every product and every process has an associated risk. Although there are some examples of the use of quality risk management in the FDA-regulated industry today, they are limited and do not represent the full contribution that risk management has to offer. The present FDA focus on risk-based determination is requiring that the regulated industries improve dramatically their understanding and capability of hazard control concepts. In addition, the importance of quality systems has been recognized in the life sciences industry, and it is becoming evident that quality risk management is a valuable component of an effective quality system. The purpose of this book is to offer a systematic and very 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 practices or good laboratory practices. The content of this book will provide FDA-regulated manufacturers with a framework within which experience, insight, and judgment are applied systematically to manage the risks associated with their products. Manufacturers in other industries may use it as an informative guidance in developing and maintaining a risk management system and process. The two appendices add even more insight: Appendix A contains general examples of risk management, while Appendix B includes 10 case studies illustrating real examples of the quality risk management process across the medical product arena.

Design Controls for the Medical Device Industry
Design Controls for the Medical Device Industry

Author: Marie Teixeira

Publisher: CRC Press

Published: 2002-09-20

Total Pages: 258

ISBN-13: 9780203909386

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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 CONTROLS, RISK MANAGEMENT & PROCESS VALIDATION FOR MEDICAL DEVICE PROFESSIONALS
DESIGN CONTROLS, RISK MANAGEMENT & PROCESS VALIDATION FOR MEDICAL DEVICE PROFESSIONALS

Author: Vernon M. Geckler

Publisher: Wasatch Consulting Resources LLC

Published: 2017-02-11

Total Pages: 441

ISBN-13: 0692835415

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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.

Medical Device Software Verification, Validation and Compliance
Medical Device Software Verification, Validation and Compliance

Author: David A. Vogel

Publisher: Artech House

Published: 2011

Total Pages: 445

ISBN-13: 1596934239

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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."

The Changing Economics of Medical Technology
The Changing Economics of Medical Technology

Author: Institute of Medicine

Publisher: National Academies Press

Published: 1991-02-01

Total Pages: 225

ISBN-13: 030904491X

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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.

Medical Device Regulations
Medical Device Regulations

Author: Michael Cheng

Publisher: World Health Organization

Published: 2003-09-16

Total Pages: 54

ISBN-13: 9241546182

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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.

Risk Management Handbook for Health Care Organizations
Risk Management Handbook for Health Care Organizations

Author: American Society for Healthcare Risk Management (ASHRM)

Publisher: John Wiley & Sons

Published: 2009-03-27

Total Pages: 672

ISBN-13: 0470443715

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Risk Management Handbook for Health Care Organizations, Student Edition This comprehensive textbook provides a complete introduction to risk management in health care. Risk Management Handbook, Student Edition, covers general risk management techniques; standards of health care risk management administration; federal, state and local laws; and methods for integrating patient safety and enterprise risk management into a comprehensive risk management program. The Student Edition is applicable to all health care settings including acute care hospital to hospice, and long term care. Written for students and those new to the topic, each chapter highlights key points and learning objectives, lists key terms, and offers questions for discussion. An instructor's supplement with cases and other material is also available. American Society for Healthcare Risk Management (ASHRM) is a personal membership group of the American Hospital Association with more than 5,000 members representing health care, insurance, law, and other related professions. ASHRM promotes effective and innovative risk management strategies and professional leadership through education, recognition, advocacy, publications, networking, and interactions with leading health care organizations and government agencies. ASHRM initiatives focus on developing and implementing safe and effective patient care practices, preserving financial resources, and maintaining safe working environments.

Research Anthology on Privatizing and Securing Data
Research Anthology on Privatizing and Securing Data

Author: Management Association, Information Resources

Publisher: IGI Global

Published: 2021-04-23

Total Pages: 2188

ISBN-13: 1799889556

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With the immense amount of data that is now available online, security concerns have been an issue from the start, and have grown as new technologies are increasingly integrated in data collection, storage, and transmission. Online cyber threats, cyber terrorism, hacking, and other cybercrimes have begun to take advantage of this information that can be easily accessed if not properly handled. New privacy and security measures have been developed to address this cause for concern and have become an essential area of research within the past few years and into the foreseeable future. The ways in which data is secured and privatized should be discussed in terms of the technologies being used, the methods and models for security that have been developed, and the ways in which risks can be detected, analyzed, and mitigated. The Research Anthology on Privatizing and Securing Data reveals the latest tools and technologies for privatizing and securing data across different technologies and industries. It takes a deeper dive into both risk detection and mitigation, including an analysis of cybercrimes and cyber threats, along with a sharper focus on the technologies and methods being actively implemented and utilized to secure data online. Highlighted topics include information governance and privacy, cybersecurity, data protection, challenges in big data, security threats, and more. This book is essential for data analysts, cybersecurity professionals, data scientists, security analysts, IT specialists, practitioners, researchers, academicians, and students interested in the latest trends and technologies for privatizing and securing data.

Medical Regulatory Affairs
Medical Regulatory Affairs

Author: Jack Wong

Publisher: CRC Press

Published: 2022-01-27

Total Pages: 806

ISBN-13: 1000440516

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This handbook covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. It is the first to cover the medical device regulatory affairs in Asia. Experts from influential international regulatory bodies, including the US Food and Drug Administration (FDA), UK Medicines and Healthcare Products Regulatory Agency, Japan Pharmaceuticals and Medical Devices Agency, Saudi Food and Drug Authority, Korea Testing Laboratory, Taiwan FDA, World Health Organization, Asian Harmonization Working Party, Regulatory Affairs Professionals Society, and British Standards Institution, have contributed to the book. Government bodies, the medical device industry, academics, students, and general readers will find the book immensely useful for understanding the global regulatory environment and in their research and development projects.