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 Traditional 510(K) Submission – A Step by Step Process
In the United States, medical devices are regulated under the Fed...
Medical Devices – USA/Europe/Asia Regulatory Updates Roundup, Apr 2023
USA (FDA) | CANADA (HEALTH CANADA) | EUROPE | SWITZERLAND (SWISS ...
eSTAR Pilot by the US FDA and Health Canada
The U.S. Food & Drug Administration (FDA) and Health Canada h...