UK MHRA Extending Acceptance of CE Devices
The Medicines & Healthcare products Regulatory Agency (MHRA), ...
New EU MDR/IVDR Authorized Representative guidance summary
For manufacturers who are not established in the European Union, t...
Trend reporting in IVDR context and Requirements
Manufacturers of devices, made available on the Union market, othe...
Medical Devices – USA/Europe Regulatory Updates Roundup, Apr 2022
EUROPE (EU) | USA (FDA) | ROW – BRAZIL (ANVISA)
EUROPE (EU) ...
A Guide for Medical Device Organizations in Clinical Evaluation Report (CER) Submission
Launching a new medical device in the market always need a Clinica...
8 key Questions & Responses on Clinical Investigation under EU MDR
1: Difference between the performance, clinical performance and cl...
