Quality First International

"Biological Safety & European Medical Device Regulations"

Author:

JJB Tinkler, UK Department of Health

Price:

Paperback book: £49.99 (plus postage)
RRP: £150   l   You save: 33%

PDF version: £49.99 (by email)
RRP: £150   l   You save: 33%

With the ever-increasing use of biomaterials in the construction of medical devices, manufacturers must assume some responsibility in ensuring materials are safe.

This Guidance handbook is the first text to explore the fundamentals of biological evaluation and European medical device regulations. The meaning of biological safety is discussed in relation to the definition of testing programmes' use of toxicological information and the burden of proof needed to satisfy the relevant Essential Requirements of Council Directive 93/42/EEC and other Directives concerned with medical devices.

The utility of EN ISO 10993-1 and other recognised texts in support of placement of medical devices on the market is studied in detail, providing insight to the student on how the biological safety profile of given devices might be approached.

Tinklerís book is an invaluable addition to the toxicologist, regulatory assurance specialist and designer of medical devices, as well as to the corresponding regulatory scientists likely to be the arbiter of a particular deviceís biocompatibility.

Quality First International Pressís "Guidance onÖ" Handbooks are a refreshing means of coming to terms with these complex requirements. They aim to provide a comprehensive and illustrative way of understanding the practical implications of EU regulations, using selected medical device model sectors to explore what is needed, explain the options available and provide ready worked examples for achieving compliance. This series has been prepared from first-hand experience and expertise of specialists from Competent Authority, Notified Body and further regulatory, device technology, and academic disciplines and will form an essential guide through all relevant areas. The approach taken in the handbook is appropriate for all managers, specialists and practitioners in any disciplines involved with the design, development, manufacture, distribution, quality, regulation and maintenance of medical devices in the manufacturing sector, regulatory authorities and related organisations. Uniquely this series provides detailed, comprehensive accounts of each requirement in turn; their associated or invoked controls and, using the theme of CE marking throughout, presents sound, practical advice on solutions for achieving compliance.

Read the review

Download an independent review of this book by Mel Stratmeyer of the US Food & Drug Administration as published in the November 2004 issue of the Journal of Medical Device Regulation.

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