GMP Publications - Code of Federal Regulation Handbooks by the FDA

Medical Device Combination 2 - 21 CFR Part 11, Part 820 and EU 2017/745

11.820.MedDeviceDirectiveEU2017.745
978-1-935131-56-4

US FDA Title 21 CFR Parts

Part 11 - Electronic Records/Electronic Signatures (ERES)
Part 820 - Quality Systems Regulations

EU Medical Device Regulation 2017/745

























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