{"product_id":"medical-device-regulation-fda-cdrh-manufacturing-policies-and-regulation-handbook-paperback-9780323953542","title":"Medical Device Regulation; FDA-CDRH Manufacturing, Policies and Regulation Handbook (Paperback \/ softback) 9780323953542","description":"\u003cfont face=\"Georgia\"\u003e\r\n\u003cp\u003e\u003cfont size=\"6\"\u003eMedical Device Regulation\u003c\/font\u003e\u003cbr\u003e\r\n\u003cfont size=\"5\"\u003eFDA-CDRH Manufacturing, Policies and Regulation Handbook\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cem\u003eAssists medical device manufacturers both in and out of the U.S. with premarket application and meeting complex FDA regulatory requirements\u003c\/em\u003e\u003c\/p\u003e\r\n\r\n\r\n\u003cp\u003e\u003cfont size=\"4\"\u003eElijah Wreh (Author)\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003e9780323953542, Elsevier Science\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003ePaperback \/ softback, published 24 February 2023\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003e678 pages\u003cbr\u003e23.5 x 19 x 4.1 cm, 1.4 kg\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\r\n\r\n\r\n\r\n\u003cp align=\"justify\"\u003e\u003cstrong\u003e\u003cfont size=\"3\"\u003e\u003ci\u003eMedical Device Regulation\u003c\/i\u003e provides the current FDA-CDRH thinking on the regulation of medical devices. 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.\u003c\/font\u003e\u003c\/strong\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003e\u003cp\u003e\u003cb\u003eSection 1: How to Study and Market a Medical Device\u003c\/b\u003e 1. Overview of Medical Device Regulation 2. Regulatory Routes to Market a Medical Device 3. Premarket Notification 510(k)  4. Device Modifications Requiring new 510(k) Submission 5. Premarket Approval (PMA) 6. Investigational Device Exemption (IDE) 7. In Vitro Diagnostics 8. Clinical Studies for Medical Device 9. Medical Device Labeling 10. FDA Advisory Committees 11. Human Factors and Medical Devices 12. Mobile Medical Applications 13. Software, Cybersecurity and Wireless Coexistence \u003c\/p\u003e \u003cp\u003e\u003cb\u003eSection 2: Postmarket Activities and FDA Collaboration\u003c\/b\u003e 14. Postmarket Activities and Requirements 15. Compliance and Enforcement 16. Quality System Regulation (QRS) 17. Risk Management 18. Meeting and Collaboration with FDA 19. Future of Medical Device Regulation\u003c\/p\u003e \u003cp\u003eAppendix A: FDA Guidance Documents (Medical Devices) B: Regulatory Affairs Certification (Devices) Practice Exam Questions C: Quality Management System (QMS) Manual \u003c\/p\u003e\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003eSubject Areas: Engineering: general [\u003ca title=\"See our other books on Engineering: general\" href=\"https:\/\/freshlyprintedbooks.co.uk\/search?q=%22Engineering:%20general%20%5BTBC%5D%22\"\u003eTBC\u003c\/a\u003e]\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\r\n\u003c\/font\u003e","brand":"Academic Press","offers":[{"title":"Default Title","offer_id":46651192901912,"sku":"9780323953542","price":133.99,"currency_code":"GBP","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0730\/2037\/5320\/products\/9780323953542_78a3cee1-ba14-46c7-8a80-1c34d44a3e2a.jpg?v=1694993636","url":"https:\/\/freshlyprintedbooks.co.uk\/products\/medical-device-regulation-fda-cdrh-manufacturing-policies-and-regulation-handbook-paperback-9780323953542","provider":"Freshly Printed Books","version":"1.0","type":"link"}