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A collection of resources on SaMD and medical device regulation.
Guidance on defining intended purpose for Software as a Medical Device (SaMD), to help SaMD manufacturers in meeting their statutory obligations. Find out more
FDA regulates the sale of medical device products in the U.S. and monitors the safety of all regulated medical products.Find out more
Medical devicesFind out more
Resources related to and required for sale of medical devices in Canada including legislation, Health Canada guidelines, applications and submissions, fees, licences and quality system requirementsFind out more
The International Medical Device Regulators Forum (IMDRF) aims to accelerate international medical device regulatory harmonization and convergence.Find out more
Medical devices and In Vitro Diagnostic medical devices (IVDs) have a fundamental role in saving lives by providing innovative healthcare solutions…Find out more