FDA The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published detailed guidance dedicated to software validation. The document covers the most important aspects related to the general principles...
Asia The Health Sciences Authority (HSA), Singapore’s regulating authority in the sphere of medical devices and other healthcare products, has published a guidance document dedicated to software medical devices in the context of a life cycle approach. The document provides...
Australia and Oceania The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of healthcare products, has published a guidance document dedicated to software-based medical devices. In particular, the document provides examples of software products that...
Asia The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to the life cycle approach in the context of software medical devices. Apart from other aspects, the document addresses...
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 main principles of software validation. The document is intended to assist medical device...
