EO Sterilization; EPA Mandate; Alternates from FDA
In April, the U.S. Environmental Protection Agency proposed limiti...
Medical Devices – USA/Europe/Asia Regulatory Updates Roundup, June 2023
USA | EUROPE | ASIA
USA (FDA) Non-Clinical Performance Assessment ...
UK MHRA Extending Acceptance of CE Devices
The Medicines & Healthcare products Regulatory Agency (MHRA), ...
Medical Devices – USA/Europe/Asia Regulatory Updates Roundup, May 2023
USA (FDA) | EUROPE | FINLAND (FIMEA) | SPAIN (AEMPS) | UNITED KING...
Adverse Event Reporting in UK – SaMD
Any event which meets these three reporting criteria is considered...
Medical Devices – USA/Europe/Asia Regulatory Updates Roundup, Apr 2023
USA (FDA) | CANADA (HEALTH CANADA) | EUROPE | SWITZERLAND (SWISS M...