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2026.01.13

From the PIP Scandal to MDR: A New Era in Medical Device Regulation

2026.01.13

To What Extent Should Cybersecurity Testing Be Conducted? (Part 1 of 3)

2026.01.13

FDA’s Policy Shift: Management Review and Audit Reports Now Subject to Inspection

2026.01.13

FDA Issues Quality Management System Regulation (QMSR)

2026.01.13

Scope of Application of Usability Engineering

2026.01.13

Understanding “State of the Art” in Medical Device Risk Management

2026.01.13

Why Does the FDA Require a Design History File?

2026.01.13

Medical Device Cybersecurity Guidance and IEC 81001-5-1

2026.01.13

Understanding Process Validation in Medical Device Manufacturing

2026.01.13

History of FDA Medical Device Regulation