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openregulatory / templates

Templates for ISO 13485, IEC 62304, ISO 14971 and IEC 62366 compliance.
https://openregulatory.com/templates
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Lageso changes #6

Closed sven-pa closed 2 years ago

sven-pa commented 2 years ago

Lageso response: updated definition of serious incident | separated evaluation causal relationship <> incident | added identification of affected users (para. 5) |

sven-pa commented 2 years ago

@olieidel please give the risk table a critical check. the code drags over several lines now, not sure if that worked out well.