BS EN ISO 14971:2019 PDF

What is this standard about? Recognized by regulatory authorities in the US, Canada, Europe and more, this international standard helps medical device manufacturers establish, document and maintain a systematic risk management process across all phases of the lifecycle of a medical device. Use of the standard helps streamline the regulatory processes that enable entry to selected markets. Who is this standard for? It will be used by all parts of the medical device industry, and by organizations dealing with the design, development, production, installation or servicing of medical equipment, devices and technology. Why should you use this standard? BS EN specifies terminology, principles and a process for medical devices risk management, including software as a medical device and in vitro diagnostic medical devices. The process described will help medical device manufacturers: