BS EN ISO 14971:2019

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 ISO 14971 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:

Identify the hazards associated with the medical device Estimate and evaluate the associated risks Control these risks Monitor the effectiveness of the controls

The standard’s requirements apply to all phases of the life cycle of a medical device. The process described applies to risks associated with a medical device, such as those related to biocompatibility, data and systems security, electricity, moving parts, radiation and usability. It can also be applied to products that are not necessarily medical devices in some jurisdictions and can also be used by others involved in the medical device lifecycle. NOTE 1: This document does not apply to decisions on the use of a medical device in the context of any particular clinical procedure or business risk management.
NOTE 2: The standard requires manufacturers to establish objective criteria for risk acceptability but does not specify acceptab...