Medical Devices – USA, Europe and Asia Regulatory Updates Roundup – Jan 2025
USA
Guidance on Premarket Approval Application and Humanitarian D...
US FDA’s UDI Requirements
FDA UDI regulations were released in the final UDI Rule on Septem...
10 Simple Rules for Handling Meta-Analyses
The Basic principle involved in Meta-analysis is a relatively new...
EU Annual Report on Clinical Evaluation (CECP)
The European Commission (EC) published its first annual report ab...
A Guide for Medical Device Organizations in Clinical Evaluation Report (CER) Submission
Launching a new medical device in the market always need a Clinic...
Medical Device Risk Management Myths and How to Avoid Them
From a distance view risk management seems simple and straightfor...
