{"product_id":"medical-device-regulation-fda-cdrh-manufacturing-policies-and-regulation-handbook","title":"Medical Device Regulation FDA-CDRH Manufacturing, Policies and Regulation Handbook by Elijah Wreh","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\u003cul\u003e \u003cli\u003eOffers a unique focus on the regulatory affairs industry, specifically targeted at regulatory affairs professionals and those seeking certification\u003c\/li\u003e \u003cli\u003ePuts regulations in the context of contemporary design\u003c\/li\u003e \u003cli\u003eIncludes case studies and applications of regulations\u003c\/li\u003e\n\u003c\/ul\u003e","brand":"Elsevier Science","offers":[{"title":"Default Title","offer_id":55700730052899,"sku":"9780323953542","price":47.99,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0982\/7336\/2211\/files\/8761053482303.jpg?v=1791037897","url":"https:\/\/agourabookcellar.com\/products\/medical-device-regulation-fda-cdrh-manufacturing-policies-and-regulation-handbook","provider":"Agoura Book Cellar","version":"1.0","type":"link"}