RAAML 1.1 RTF Avatar
  1. OMG Issue

RAAML11 — Add Method::ISO 14971 (Application of risk management to medical devices)

  • Key: RAAML11-18
  • Status: open  
  • Source: oose Innovative Informatik eG ( Mr. Axel Scheithauer)
  • Summary:

    We suggest to add a new method for risk management for medical devices according to ISO 14971.

    In the context of the medicussy project we have created a profile and a library. These could be used as a starting point. The files can be found in a github-repository: https://github.com/oose/medicussy. There you also find further example models that illustrate the application of the method.

    We invite everybody to contribute to the github repository.

  • Reported: RAAML 1.0b1 — Mon, 12 Dec 2022 16:21 GMT
  • Updated: Thu, 5 Oct 2023 00:15 GMT