Software-Based Diabetes Treatment: The Future of Digital Therapeutics (DTx)
Trends in Medical Device Shortage Reporting
The EU AI Act and SaMD Development
From the PIP Scandal to MDR: A New Era in Medical Device Regulation
To What Extent Should Cybersecurity Testing Be Conducted? (Part 1 of 3)
FDA’s Policy Shift: Management Review and Audit Reports Now Subject to Inspection
FDA Issues Quality Management System Regulation (QMSR)
Scope of Application of Usability Engineering