In Vitro Diagnostic Regulation (IVDR) – General Aspects, Key features and Limitations
Introduction to IVDR:
The In Vitro Diagnostic Regulation (IVDR) re...
EU Med Devices: Increase in MDR applications
Last year the European commission has collected the data from the ...
Using Benchmarks to Show Compliance EU MDR and EU IVDR
Benchmarking is a formal procedure of evaluation in a process or s...
EU IVDR Performance Validation Report: Steps and Requirements
European Union in Vitro Diagnostic Regulation (EU IVDR) 2017/746 i...
EO Sterilization; EPA Mandate; Alternates from FDA
In April, the U.S. Environmental Protection Agency proposed limiti...
BioPharma – USA/Europe/Asia Regulatory Updates, May 2023
ASIA | EUROPE | USA US FDA Seeks Comments on Proposed Consumer Rx ...
