Good Manufacturing Practices (GMP)

EU Medical Device Regulation (EU MDR) – Chapter 10 – Final Provisions

EU Medical Device Regulation (EU MDR) – Chapter 8 – Cooperation Between Member States

The Lifecycle of a Change Control Program – Examples of Change Controls, Documents & Recording Completed Changes

MDSAP Country Specific Requirements (Japan)

ISO 14971:2019: Different Perspectives of a Risk Management Program

MDSAP Country Specific Requirements (Brazil)

ISO 14971:2019: Risk Analysis, Evaluation & Control

MDSAP Country Specific Requirements (Australia)

Commissioning Qualification and Validation the Concept of CQV – Part 3

ISO 14971: Characterizing the Device & Identifying Hazards