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