IVDR New Guidance on Safety Reporting in Performance Studies
The Medical Device Coordination Group (MDCG) has r...
Medical Devices – USA/Europe/Asia Regulatory Updates Roundup, April 2024
USA
FDA Data Standards Catalog Version 10.3
The FD...
BioPharma – USA/Europe/Asia Regulatory Updates, April 2024
USA Content and Format of Composition Statements i...
A simple Glance of Log Rank Test in Survival Analysis for Clinical Trial Data Analysis
In clinical trials, especially in cancer clinical ...
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...
