Using Benchmarks to Show Compliance EU MDR and EU IVDR
Benchmarking is a formal procedure of evaluation in a process or s...
Requirements of SSCP (Summary of Safety and Clinical Performance)
What is SSCP? The SSCP (Summary of Safety and Clinical Performance...
Post-Market Surveillance Requirements for Medical Devices
Post-Market Surveillance requirements for Medical devices as per E...
Medical Device Clinical Investigations
The EU 2017/745 new Medical Device Regulation was approved by the ...
Medical Devices – USA/Europe/Asia Regulatory Updates Roundup, Oct 2023
USA | EUROPE | ASIA
USA Guiding Principles on Predetermined Change...
IVDR Performance Evaluation: An Executive Overview
Introduction
In vitro diagnostic (IVD) devices are essential compo...
