{"product_id":"medical-device-regulation-elijah-wreh-9780323953542","title":"Medical Device Regulation: Fda-Cdrh Manufacturing, Policies and Regulation Handbook","description":"\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.\u003cbr\u003e\u003cbr\u003e\u003cb\u003eAuthor:\u003c\/b\u003e Elijah Wreh\u003cbr\u003e\u003cb\u003eISBN-10:\u003c\/b\u003e 0323953549\u003cbr\u003e\u003cb\u003eISBN-13:\u003c\/b\u003e 9780323953542\u003cbr\u003e\u003cb\u003ePublisher:\u003c\/b\u003e Academic Press\u003cbr\u003e\u003cb\u003eLanguage:\u003c\/b\u003e English\u003cbr\u003e\u003cb\u003ePublished:\u003c\/b\u003e 02\/24\/2023\u003cbr\u003e\u003cb\u003ePages:\u003c\/b\u003e 678\u003cbr\u003e\u003cb\u003eFormat:\u003c\/b\u003e Paperback\u003cbr\u003e\u003cb\u003eWeight:\u003c\/b\u003e 2.53lbs\u003cbr\u003e\u003cb\u003eSize:\u003c\/b\u003e 9.25h x 7.50w x 1.36d","brand":"Elijah Wreh","offers":[{"title":"Paperback","offer_id":44070674071807,"sku":"9780323953542","price":200.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0662\/2982\/9887\/files\/img_f5304349-9f2b-4606-8e0e-f405fbbd66ad.jpg?v=1685431700","url":"https:\/\/www.whiterainbookhouse.com\/products\/medical-device-regulation-elijah-wreh-9780323953542","provider":"WR Book House","version":"1.0","type":"link"}