Biomedical Science

Medical Devices

Per Page:

Sterilization of Medical Devices

Anne Booth
November 30, 1998

This book presents vital information on international sterilization standards and guidance on practical application of these standards in the manufacturing process. It covers validation, industrial sterilization methods, emerging sterilization techniques, laboratory testing, manufacturing of...

Medical Device Packaging Handbook, Second Edition, Revised and Expanded

Max Sherman
August 25, 1998

This volume details current developments in industry practices and standards relating to medical device packaging. This edition offers entirely new as well as revised chapters on packaging materials, package validation and methods and integrity testing, bar-coding technology, environmentally sound...

Medical Device Quality Assurance and Regulatory Compliance

Richard C. Fries
August 11, 1998

"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."...

Pharmacetical Applications in the European Union: A Guide Through the Registration Maze

Cheng Yee Lowe
February 28, 1998

Written by an expert with twenty years' experience in regulatory affairs in a number of multi-national companies, this book guides readers through the legislative minefield of registering medicinal products in the European Union. Taking a step-by-step approach, the book demystifies all of the...

Metered Dose Inhaler Technology

Tol S. Purewal, David J.W. Grant
December 31, 1997

Metered Dose Inhaler Technology explores the technologies of pressurized metered dose inhalation (MDI) delivery systems and provides practical, easy-to-use guidance to effective product formulation. With contributions from an international panel of authors, the book addresses the global phase-out...

Validation for Medical Device and Diagnostic Manufacturers, Second Edition

Carol V. Desain, Charmaine V. Sutton
September 30, 1997

Implementation of FDA's Design Control requirements (21 CFR 820.30) changed an entire industry. Quality System Requirements defined the approach to medical device validation. Product design, manufacturing process, and test method validation studies must be performed before or as a product is...

Electromagnetic Compatibility in Medical Equipment: A Guide for Designers and Installers

William D. Kimmel, Daryl Gerke
October 01, 1995

Co-published with the IEEE Press, this book is a practical, hands-on guide to EMC issues for medical device designers and installers. It addresses electromagnetic interference and covers the basics of EMC design, physics, and installation, minimizing theory and concentrating upon the correct way to...

Szycher's Dictionary of Medical Devices

Michael Szycher
April 19, 1995

FROM THE PREFACEThe field of medical devices represents one of the most advanced technological areas in the United States. In 1991, over 12 million Americans had at least one medical device; fixation devices had the highest incidence, followed by contact lens use and lens implants and, lastly,...

Medical Device and Equipment Design: Usability Engineering and Ergonomics

Michael E. Wiklund
February 15, 1995

The key to profitability and success in both the medical device and the equipment markets often relates to how easy your products are to use. User acceptance and preference frequently is dependent upon ergonomic design.Medical Device and Equipment Design helps you enhance your product design,...

Szycher's Dictionary of Biomaterials and Medical Devices

Michael Szycher
February 23, 1992

This dictionary contains thousands of definitions from various related disciplines and minimizes the need for several dictionaries. The book defines everything from AAMI (Association for the Advancement of Medical Instrumentation) to zymogen (proenzyme). The editor, an internationally recognized...