Differences between US FDA and EU MDR Usability Studies requirements
Regulatory frameworks for usability testing
IEC 62366-1:2015 is an...
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...
eIFU for Medical Devices: Country Specific Regulations and Benefits
There are several benefits of using electronic Instructions for Us...
