Good Clinical Practices (GCP)

Change Control: Regulations and Guidelines

Computer System Validation – Application of the Validation Plan

Computer System Validation – Validation Master Plan

21 CFR Part 50 Subpart B: Informed Consent of Human Subjects [Part 2]

EU Medical Device Regulation (EU MDR) – Chapter 5: Classification and Conformity

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