RAAML 1.1 RTF Avatar
  1. OMG Issue

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

  • Key: RAAML11-18
  • Status: closed  
  • 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
  • Disposition: Deferred — RAAML 1.1
  • Disposition Summary:

    Out of scope of RAAML 1.1

    ISO 14971 is out of scope of RAAML 1.1. We will consider supporting it in the future if there enough interest from the industry.

  • Updated: Mon, 17 Jun 2024 13:38 GMT