Medical Devices – USA/Europe/Asia Regulatory Updates Roundup, June 2024
USA
Guidance on Laboratory Developed Tests: Small Entity Complian...
PMS Proactive & Reactive Data Sources for Devices
PMS processes are generating data, either continually or intermit...
EU IVDR Performance Evaluation in 8 Steps
The new revised EU Regulation 2017/746 is focusing specific guide...
Post-Market Surveillance Requirements for Medical Devices
Post-Market Surveillance requirements for Medical devices as per ...