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Author Wreh, Elijah.

Title Medical device regulation : FDA-CDRH manufacturing, policies and regulation handbook / Elijah Wreh.

Publication Info. London, United Kingdom ; San Diego, CA, United States ; Cambridge, MA, United States ; Kidlington, Oxford, United Kingdom : Elsevier, Academic Press, an Imprint of Elsevier, [2023]
©2023

Copies

Location Call No. OPAC Message Status
 Axe Elsevier ScienceDirect Ebook  Electronic Book    ---  Available
Description 1 online resource : illustrations (some color)
text txt rdacontent
computer c rdamedia
online resource cr rdacarrier
Bibliography Includes bibliographical references and index.
Note Description based on online resource; title from digital title page (viewed on April 18, 2023).
Summary This book offers information on how devices meet criteria for being a medical device, which agencies regulate medical devices, how policies regarding regulation affect the market, rules regarding marketing, and laws and standards that govern testing. This practical, well-structured reference tool helps medical device manufacturers both in and out of the United States with premarket application and meeting complex FDA regulatory requirements. The book delivers a comprehensive overview of the field from an author with expertise in regulatory affairs and commercialization of medical devices--Publisher description.
Contents Overview of medical device regulation -- How to market a medical device -- Premarket notification [510(k)] -- Device modifications requiring new 510(k) submission -- Premarket approval (PMA) -- Investigational device exemption -- In vitro diagnostics -- Clinical studies for medical device -- Medical device labeling requirements -- FDA Medical Devices Advisory Committees -- Human factors and medical devices -- Mobile medical applications, software, and wireless coexistence -- Cybersecurity in medical devices -- Postmarket surveillance and requirements -- Compliance and enforcement -- The quality system regulation -- Risk management -- Meeting and collaboration with the FDA -- Future of the medical device industry -- Appendix: FDA guidance documents (medical devices). Regulatory affairs professionals society (RAPS). Quality management system manual -- Glossary -- Index.
Subject Medical instruments and apparatus -- Safety regulations -- United States.
Medical instruments and apparatus -- Law and legislation -- United States.
Médecine -- Appareils et instruments -- Sécurité -- Règlements -- États-Unis.
Medical instruments and apparatus -- Law and legislation
Medical instruments and apparatus -- Safety regulations
United States https://id.oclc.org/worldcat/entity/E39PBJtxgQXMWqmjMjjwXRHgrq
Other Form: Print version: Wreh, Elijah. Medical device regulation. Amsterdam : Academic Press, 2023 9780323953542 (OCoLC)1350639957
ISBN 9780323953535 electronic book
0323953530 electronic book
9780323953542
0323953549
Standard No. AU@ 000073637244
UKMGB 020802909

 
    
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