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US, EU and Canadian Medical Device Combination
US, EU and Canadian Medical Device Combination
SKU:978-1-935131-28-1
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US 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 Excemptions
- Part 814 - Premarket Approval of Medical Devices
- Part 820 - Quality Systems Regulations
- PMA & 510k Guidance Document
- US FDA Inspection of Medical Device Manufacturers 7382.845
International Parts:
- Canadian Medical Device Regulations - Last Amended on February 22, 2023
-
EU 2017/745 Medical Device Regulation
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