Medical Devices – USA, Europe and Asia Regulatory Updates Roundup – Jan 2025
USA
Guidance on Premarket Approval (PMA) and Human...
New/Key MDCG guidances in 2024
The European Commission continues to refine and ex...
Medical Devices – USA/Europe/Asia Regulatory Updates Roundup, June 2024
USA
Laboratory Developed Tests (LDTs) – Small Enti...
PMS Proactive & Reactive Data Sources for Devices
PMS processes are generating data, either continua...
EU IVDR Performance Evaluation in 8 Steps
The new revised EU Regulation 2017/746 is focusing...
Post-Market Surveillance Requirements for Medical Devices
Post-Market Surveillance requirements for Medical ...
