Intermediate

EU Medical Device Regulation (EU MDR) – Chapter 4: Notified Bodies

ISO 14971 – The Scope of the Standard

MDSAP Country Specific Requirements (USA)

An Introduction to Medical Device Validation – Part 3

EU Medical Device Regulation (EU MDR) – Chapter 3: Identification, Traceability and Registration of Devices

An Introduction to Medical Device Validation – Part 2

Medical Device Single Audit Program (MDSAP) – Chapters 5 to 7

An Introduction to Medical Device Validation – Part 1

Medical Device Single Audit Program (MDSAP) – Chapters 1 to 4

21 CFR Part 211 Subpart B: Organization and Personnel