{"product_id":"9780323953542","title":"Medical Device Regulation : FDA-CDRH Manufacturing, Policies and Regulation Handbook","description":"\u003cp\u003eMedical Device Regulation 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\/p\u003e","brand":"Academic Press Inc","offers":[{"title":"Default Title","offer_id":48264291975403,"sku":"00000_00000_00000_00000","price":366.24,"currency_code":"SGD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0758\/4484\/5803\/files\/9780323953542-1.jpg?v=1781615446","url":"https:\/\/kinokuniya.com.sg\/zh\/products\/9780323953542","provider":"Books Kinokuniya Singapore","version":"1.0","type":"link"}