Add Method::ISO 14971 (Application of risk management to medical devices)
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Key: RAAML11-18
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Status: open
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Source: oose Innovative Informatik eG ( Axel Scheithauer)
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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.
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Reported: RAAML 1.0b1 — Mon, 12 Dec 2022 16:21 GMT
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Updated: Tue, 20 Dec 2022 18:18 GMT