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 ...
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 Devices – USA/Europe/Asia Regulatory Updates Roundup, Oct 2023
USA | EUROPE | ASIA
USA Guiding Principles on Predetermined Change...
Swissmedic Device/IVD Database Key Dates
Swissmedic now handles registration of economic operators, medical...
