Medical Devices – USA/Europe/Asia Regulatory Updates Roundup, June 2024
USA
Laboratory Developed Tests (LDTs) – Small Enti...
EU Portable Electronic Devices Change Requirements
Portable Electronic Devices (PED) include digital ...
Clinical Data Usage for Medical Device Submissions in EU and US
Clinical Data for Medical Device Submissions in EU...
10 Simple Rules for Handling Meta-Analyses
The Basic principle involved in Meta-analysis is a...
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...
