US FDA’s UDI Requirements
FDA UDI regulations were released in the final UDI Rule on Septemb...
BioPharma – USA/Europe/Asia Regulatory Updates, June 2024
USA
FDA Permits Marketing of First Point-of-Care Hepatitis C RNA T...
Medical Devices – USA/Europe/Asia Regulatory Updates Roundup, June 2024
USA
Guidance on Laboratory Developed Tests: Small Entity Complianc...
IVDR New Guidance on Safety Reporting in Performance Studies
The Medical Device Coordination Group (MDCG) has recently publishe...
Sterilization Regulatory Requirements and Supporting Standards
Sterilization of medical devices is a critical process integral to...
Responsibilities for Medical Devices Vigilance Reporting
Medical devices are regulated differently across the globe. Each c...
