US FDA’s UDI Requirements
FDA UDI regulations were released in the final UDI...
BioPharma – USA/Europe/Asia Regulatory Updates, June 2024
USA
FDA Permits Marketing of First Point-of-Care H...
Medical Devices – USA/Europe/Asia Regulatory Updates Roundup, June 2024
USA
Laboratory Developed Tests (LDTs) – Small Enti...
IVDR New Guidance on Safety Reporting in Performance Studies
The Medical Device Coordination Group (MDCG) has r...
Sterilization Regulatory Requirements and Supporting Standards
Sterilization of medical devices is a critical pro...
Responsibilities for Medical Devices Vigilance Reporting
Medical devices are regulated differently across t...
