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

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.

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.