US, EU and Canadian Medical Device Combination QMSR US FDA Title 21 CFR

US FDA Title 21 CFR Parts 210/211 Good Manufacturing Practices - The regulations set forth in parts 210/211 contain the minimum current good manufacturing practice for methods to be used in

Drug Manufacturing Inspections: Compliance Manual for FDA Staff (7356

and the facilities or controls to be used for

CGMP for Drugs Auditor’s Check List

Part 108 - Emergency Permit Control

US, EU and Canadian Medical Device Combination QMSR US FDA Title 21 CFRUS FDA Parts Part 11 Electronic Records Electronic Signatures (ERES) Part 50 Protection of Human Subjects Part 54 Financial Disclosure by Clinical Invest. Part 56 Institutional Review Boards Part 801 Labeling Medical Devices Part 803 Medical Device Reporting Part 806 Medical Devices; Reports of Corrections & Removals Part 807 Establishment Registration and Device Listing for Manufacturers & Initial Importers of Devices Part 812 Investigational Device