Medical Device Quality Assurance and Regulatory Compliance

"Acquaints developers of medical devices with the basic concepts and major issues of medical quality assurance and regulatory documents, describes the requirements listed in these documents, and provides strategies for compliance with these requirements."

Science & Math

Fries, Richard C.

Biological Sciences

CRC-Press

"Acquaints developers of medical devices with the basic concepts and major issues of medical quality assurance and regulatory documents, describes the requirements listed in these documents, and provides strategies for compliance with these requirements."

The Handbook of Medical Device Design provides a review of regulatory and standards issues in medical device design, including FDA regulations, types of 510 (k), the ISO 9000 series, and medical device directives. It identifies how to determine and document customer needs and device requirements. It also establishes reliability and quality metrics for the duration of the product development cycle. Topics include

Handbook of Medical Device Design

Analyzing product conception through to delivery in actual industry examples, Design of Biomedical Devices and Systems considers issues in the industrial design process exactly as they would arise in real-world applications, divulging valuable trade secrets within topics like materials selection, safety, prototyping, premarket testing and validation, liability, and learning from failure. The authors discuss product definition, development, marketing, verification, and validation; elucidate the QFD process, and address engineering licensure and codes of ethics. They also introduce new concepts in hardware and software design, including the use of computer tools to predict and document safety-related design issues.

Design of Biomedical Devices and Systems

King, Paul H.

As medical devices increase in complexity, concerns about efficacy, safety, quality, and longevity increase in stride. Introduced nearly a decade ago, Reliable Design of Medical Devices illuminated the path to increased reliability in the hands-on design of advanced medical devices. With fully updated coverage in its Second Edition, this practical guide continues to be the benchmark for incorporating reliability engineering as a fundamental design philosophy. The book begins by rigorously defining reliability, differentiating it from quality, and exploring various aspects of failure in detail. It examines domestic and international regulations and standards in similar depth, including updated information on the regulatory and standards organizations as well as a new chapter on quality system regulation. The author builds on this background to explain product specification, liability and intellectual property, safety and risk management, design, testing, human factors, and manufacturing. New topics include design of experiments, CAD/CAM, industrial design, material selection and biocompatibility, system engineering, rapid prototyping, quick-response manufacturing, and maintainability as well as a new chapter on Six Sigma for design. Supplying valuable insight based on years of successful experience, Reliable Design of Medical Devices, Second Edition leads the way to implementing an effective reliability assurance program and navigating the regulatory minefield with confidence.

Reliable Design of Medical Devices, Second Edition

Presenting the basic concepts and major issues associated with medical device design, this text describes current development processes as well as standards and regulatory information, providing a basis for assessing new technologies. It aims to help manufacturers establish and operate a viable reliability assurance programme, and purchasers to formulate effective methods of vendor evaluation.

Reliable Design of Medical Devices

Reliability Assurance for Medical Devices, Equipment and Software

Medical Books

Interpharm Pr

As medical devices become even more intricate, concerns about efficacy, safety, and reliability continue to be raised. Users and patients both want the device to operate as specified, perform in a safe manner, and continue to perform over a long period of time without failure. Following in the footsteps of the bestselling second edition, Reliable Design of Medical Devices, Third Edition shows you how to improve reliability in the design of advanced medical devices. Reliability engineering is an integral part of the product development process and of problem-solving activities related to manufacturing and field failures. Mirroring the typical product development process, the book is organized into seven parts. After an introduction to the basics of reliability engineering and failures, it takes you through the concept, feasibility, design, verification and validation, design transfer and manufacturing, and field activity phases. Topics covered include Six Sigma for design, human factors, safety and risk analysis, and new techniques such as accelerated life testing (ALT) and highly accelerated life testing (HALT). What’s New in This Edition <ul>
<li>Updates throughout, reflecting changes in the field</li> <li>An updated software development process</li> <li>Updated hardware test procedures</li> <li>A new layout that follows the product development process</li> <li>A list of deliverables needed at the end of each development phase</li>
</ul>
Incorporating reliability engineering as a fundamental design philosophy, this book shares valuable insight from the author’s more than 35 years of experience. A practical guide, it helps you develop a more effective reliability engineering program―contributing to increased profitability, more satisfied customers, and less risk of liability.

This fourth edition is a substantial revision of a highly regarded text, intended for senior design capstone courses within departments of biomedical engineering, bioengineering, biological engineering and medical engineering, worldwide. Each chapter has been thoroughly updated and revised to reflect the latest developments. New material has been added on entrepreneurship, bioengineering design, clinical trials and CRISPR. Based upon feedback from prior users and reviews, additional and new examples and applications, such as 3D printing have been added to the text. Additional clinical applications were added to enhance the overall relevance of the material presented. Relevant FDA regulations and how they impact the designer’s work have been updated. Features <ul>
<li>Provides updated material as needed to each chapter </li> <li>Incorporates new examples and applications within each chapter </li> <li>Discusses new material related to entrepreneurship, clinical trials and CRISPR </li> <li>Relates critical new information pertaining to FDA regulations. </li> <li>Presents new material on "discovery" of projects "worth pursuing" and design for health care for low-resource environments</li> <li>Presents multiple case examples of entrepreneurship in this field</li> <li>Addresses multiple safety and ethical concerns for the design of medical devices and processes</li> </ul>

Design of Biomedical Devices and Systems, 4th edition

Johnson, Arthur T.

The design and functional complexity of medical devices and systems has increased during the past half century, evolving from the level of cardiac pacemakers to magnetic resonance imaging devices. Such life-saving advancements are monumentally advantageous, but with so much at stake, a step-by-step manual for biomedical engineers is essential. This edition of a bestselling textbook utilizes a strong design perspective to provide designers with a thorough overview of the field, including topics related to databases, process analysis, and device improvement. Covers All Necessary Design Aspects for Advanced Biomedical Projects Designed primarily for senior bioengineering students in the formative stages of planning their design project, Design of Biomedical Devices and Systems is also beneficial to graduate students in the field and practitioners working with medical devices. This standard-setting resource includes: <ul>
<li>A variety of open-ended design problems and examples</li> <li>An overview of device definitions and reliability</li> <li>A discussion of testing and hardware verification and validation principles</li> <li>Detailed photographs and illustrations within each chapter</li>
</ul>
Systematic approaches to device development and maintenance are mandated to ensure safe and effective devices for the patient, an economical and competitive success for the manufacturer, and a reliable, cost-effective investment for the user. This authoritative textbook answers the call. A solutions manual is available for instructors wishing to convert this reference to classroom use.

Design of Biomedical Devices and Systems Second edition

See the best price to sell, buy, or rent books by Fries, Richard C.. BookScouter helps to compare book prices from 25+ online bookstores and 30+ buyback vendors with a single search.

Books by Fries, Richard C.

See the best price to sell, buy, or rent books by Fries, Richard C.. BookScouter helps to compare book prices from 25+ online bookstores and 30+ buyback vendors with a single search.

Medical Device Quality Assurance and Regulatory Compliance

Medical Device Quality Assurance and Regulatory Compliance

Handbook of Medical Device Design

Design of Biomedical Devices and Systems

Reliable Design of Medical Devices, Second Edition

Reliable Design of Medical Devices

Reliability Assurance for Medical Devices, Equipment and Software

Reliable Design of Medical Devices

Design of Biomedical Devices and Systems, 4th edition

Design of Biomedical Devices and Systems Second edition