Steps to Implement ISO 13485 for New Medical Device Vendors
For medical device vendors entering the industry, obtaining ISO 13...
US FDA Requirements for Design Verification and Design Validation Activities
What is Design Verification?
Design Verification is a critical ste...
Swissmedic Device/IVD Database Key Dates
Swissmedic now handles registration of economic operators, medical...
Medical Devices – USA/Europe/Asia Regulatory Updates Roundup, June 2023
USA | EUROPE | ASIA
USA (FDA) Non-Clinical Performance Assessment ...
Medical Devices – USA/Europe/Asia Regulatory Updates Roundup, May 2023
USA (FDA) | EUROPE | FINLAND (FIMEA) | SPAIN (AEMPS) | UNITED KING...
