{"product_id":"euuscandevice5-htm","title":"US, EU and Canadian Medical Device Combination","description":"\u003cp\u003e\u003cb\u003eUS FDA Parts\u003c\/b\u003e\u003c\/p\u003e\n\u003cul\u003e\n\u003cli\u003e\u003cspan\u003ePart 11 - Electronic Records\/Electronic Signatures (ERES)\u003c\/span\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cspan\u003ePart 50 - Protection of Human Subjects\u003c\/span\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cspan\u003ePart 54 - Financial Disclosure by Clinical Invest.\u003c\/span\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cspan\u003ePart 56 - Institutional Review Boards\u003c\/span\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cspan\u003ePart 801 - Labeling Medical Devices\u003c\/span\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cspan\u003ePart 803 - Medical Device Reporting\u003c\/span\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cspan\u003ePart 806 - Medical Devices; Reports of Corrections \u0026amp; Removals\u003c\/span\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cspan\u003ePart 807 - Establishment Registration and Device Listing for Manufacturers \u0026amp; Initial Importers of Devices\u003c\/span\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cspan\u003ePart 812 - Investigational Device Excemptions\u003c\/span\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cspan\u003ePart 814 - Premarket Approval of Medical Devices\u003c\/span\u003e\u003c\/li\u003e\n\u003cli\u003ePart 820 - Quality Management System Regulations (QMSR) 2026\u003c\/li\u003e\n\u003cli\u003e\u003cspan\u003ePMA \u0026amp; 510k Guidance Document\u003c\/span\u003e\u003c\/li\u003e\n\u003cli\u003e\n\u003cspan\u003e\u003c\/span\u003e\u003cspan\u003eUS FDA Inspection of Medical Device Manufacturers 7382.845\u003c\/span\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003e\u003cstrong\u003eInternational Parts:\u003c\/strong\u003e\u003c\/p\u003e\n\u003cul\u003e\n\u003cli\u003e\u003cspan\u003eCanadian Medical Device Regulations - Last Amended on February 22, 2023\u003c\/span\u003e\u003c\/li\u003e\n\u003cli\u003e\n\u003cspan\u003eEU 2017\/745 Medical Device Regulation\u003c\/span\u003e\u003cbr\u003e\u003cbr\u003e\u003cbr\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e","brand":"GMP Publications","offers":[{"title":"Default Title","offer_id":46993533370603,"sku":"978-1-935131-28-1","price":30.95,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0790\/1498\/5963\/files\/US.EU.CANMDR.2017.745.jpg?v=1763428368","url":"https:\/\/gmppublications.com\/products\/euuscandevice5-htm","provider":"GMP","version":"1.0","type":"link"}