Medical Devices – USA/Europe/Asia Regulatory Updates Roundup, June 2024
USA
Guidance on Laboratory Developed Tests: Small Entity Complianc...
EU Portable Electronic Devices Change Requirements
Portable Electronic Devices (PED) include digital cameras, smartph...
Clinical Data Usage for Medical Device Submissions in EU and US
Clinical Data for Medical Device Submissions in EU
Clinical data f...
10 Simple Rules for Handling Meta-Analyses
The Basic principle involved in Meta-analysis is a relatively new ...
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...
