Residual Risk Analysis and User Interaction Problems: Risk Management under EU MDR
Under the EU MDR, Risk is defined as the combination of the proba...
General Safety and Performance Requirements (GSPR)
What is GSPR? The GSPR is known as General Safety and Per...
Differences between US FDA and EU MDR Usability Studies requirements
Regulatory frameworks for usability testing
IEC 62366-1:2015 is a...
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 ...
UK MHRA Extending Acceptance of CE Devices
The Medicines & Healthcare products Regulatory Agency (MHRA),...