Good Clinical Practices (GCP)

21 CFR Part 50 Subpart B: Informed Consent of Human Subjects [Part 1]

ISO 14971:2019: The Evolution and Definitions

Computer System Validation – Risk Management

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

ISO 14971 – The Scope of the Standard

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

An Introduction to Medical Device Validation – Part 1

EU Medical Device Regulation (EU MDR) – Chapter 2: Making Available on the Market