Document and Record Management in Regulated Industries
Revisions to Japan’s Medical Device Quality Management System Ordinance
Distinguishing Between “Misuse” and “Use Error” in Medical Device Regulation
Regarding “Heavy” Quality Management Systems
FDA Recognition of ISO 14971:2019 as a Consensus Standard
ISO 14971:2019 Revisions – Part 2: Management Responsibility, Risk Analysis, and Risk Management File
Revisions to ISO 14971:2019 (Part 1)
Evolution of Risk Management in Medical Devices: The Significance of ISO 14971 Revision