How Unique Device Identification (UDI) Transforms Global Medical Device Compliance
Compliance is very critical to the use of safe and effective medi...
Steps to Implement ISO 13485 for New Medical Device Vendors
What is ISO 13485?ISO 13485, is specific to the medical device in...
US FDA Requirements for Design Verification and Design Validation Activities
What is Design Verification?
Design Verification is a critical st...
Swissmedic Device/IVD Database Key Dates
Swissmedic now handles registration of economic operators, medica...
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 KIN...