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 in the context of medical devices. Among other matters, the document addresses aspects...
Canada Health Canada, the country’s regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the regulatory requirements for the investigation of reported medical device problems. The document provides additional...
FDA The Food and Drugs Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to infusion pumps. The guidance highlights matters related to performance testing. It is important to...
Asia The Health Sciences Authority (HSA), Singapore’s regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the registration of medical devices. Apart from the general requirements for registration of medical devices...
FDA The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published a guidance document dedicated to the postmarket management of cybersecurity in medical devices. The document highlights the most important...
Uncategorized The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the regulatory requirements to be applied in the case of software intended to be used with rapid...
