Medical Device Instruments
Revisions have been made to the ISO 14971 regulation: medical devices - application of risk management to medical devices.
The revision aims to explain the technical requirements by including more detailed information on the course of action manufactures must take to meet those requirements. It also covers the application of risk management to medical devices.
ISO 14971 and Risk Management helps manufacturers identify and understand hazards and prevent failures associated with medical devices. Risk analysis is key in the development and design of medical devices.