Medical Devices – USA/Europe/Asia Regulatory Updates Roundup, Aug 2024
USA
Voluntary Malfunction Summary Reporting (VMSR) Program for Ma...
Clinical Data Usage for Medical Device Submissions in EU and US
Clinical Data for Medical Device Submissions in EU
Clinical data ...
In Vitro Diagnostic Regulation (IVDR) – General Aspects, Key features and Limitations
Introduction to IVDR:
The In Vitro Diagnostic Regulation (IVDR) r...
Technical Documentation Best Practices for EU MDR
Manufacturers shall ensure the conformity of medical devices bein...
Post-Market Surveillance Requirements for Medical Devices
Post-Market Surveillance requirements for Medical devices as per ...
Medical Device Clinical Investigations
The EU 2017/745 new Medical Device Regulation was approved by the...
