Category
page 1Regulation of medical devices
ISO 13485
ISO standard
Medicines and Healthcare products Regulatory Agency
Medicine regulation agency in the UK
Health Canada
Department of the Canadian Government that oversees public health
Notified Body
European Union regulatory body
Medical device regulation
political regulation
ISO 14971
ISO standard for the application of risk management to medical devices
Medical Devices Directive
EU directive
Therapeutic Goods Administration
regulatory body for therapeutic goods (including medicines, medical devices, gene technology, and blood products) in Australia
postmarketing surveillance
practice of monitoring the safety of a pharmaceutical drug or medical device after it has been released on the market