ISO 14971 Risk Management for Medical Devices
This standard specifies terminology, principles and a process for ...
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 ...
IND and NDA applications: US
The two primary application types for the approval of new drugs: T...
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...
