GMP Publications - Code of Federal Regulation Handbooks by the FDA

Medical Device Combination 2

10Part11.820.jpg
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 Directive 93/42/EEC Updated 2007/47/EC September 2007

























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