MHRA Final Rules for Post-Market Surveillance
Medicines and Healthcare Products Regulatory Agency (MHRA) finaliz...
BioPharma – USA/Europe/Asia Regulatory Updates, July 2024
USA The FDA approved Femlyv (norethindrone acetate and ethinyl est...
US FDA Traditional 510(K) Submission – A Step by Step Process
In the United States, medical devices are regulated under the Fede...
In Vitro Diagnostic Regulation (IVDR) – General Aspects, Key features and Limitations
Introduction to IVDR:
The In Vitro Diagnostic Regulation (IVDR) re...
Technical Documentation Best Practices for EU MDR
Manufacturers shall ensure the conformity of medical devices being...
High Level Approach for PMCF Activities
The Medical Devices field is a constantly moving area. Several dev...
