The Risk Management File
The risk management file as an element of the technical documentation documents all activities that are planned and executed in the context of risk management. For you as the manufacturer it is documented proof that you completed all required activities.
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"Directive 93/42/EEC, DIN EN 60601-1, DIN EN ISO 10993-1, DIN EN 62304, DIN EN 62366… Did you really consider everything?"