FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to design control. The document covers the regulatory matters related to design verification and...
Canada
Health Canada, the country’s regulating authority in the sphere of medical devices and other healthcare products, has published a guidance document dedicated to the investigation of reported medical device problems. The document is intended to provide medical device...
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to reprocessing medical devices in healthcare institutions. The document describes the validation...
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of healthcare products, has published a guidance document describing changes to the regulatory framework for software-based medical devices. The document describes the...
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the content of premarket submissions for software contained in medical devices. The document provides...
EU MDR/IVDR
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission responsible for regulations in the sphere of medical devices, has published guidance for notified bodies, distributors, and importers on certification activities in accordance...
