This is a popular misconception.
Manufacturers of medical devices have been using some form of risk analysis or management for a lot of time (I usually say, if they didn´t, things would already exploded a long time ago :-)). One of the tools commonly used is FMEA. The basic idea of FMEA that you can estimate what happens when some part/component/function of a device fails. FMEA can be extended to processes or application of a device.
FMEA, as well as FTA, HAZOP, etc., are, in the view of ISO 14971 and other ISO and IEC publications, “techniques” which might be used to help in the risk management process. For example, you can use them to identify some of the information of clause 4 – risk analysis of ISO 14971, as seen o nthe flowchart below (which does not cover all requirements of ISO 14971). However, it cannot be used for the whole process.
