ISO14971 Review - Githubissues

eQualityTime / TheOpenVoiceFactory

The Open Voice Factory - open software for people with communication difficulties

http://theopenvoicefactory.org

23 stars 9 forks source link

Closed greg-westnine closed 3 years ago

greg-westnine commented 5 years ago

Review policy and register against 14971

greg-westnine commented 5 years ago

Points to take into account:

Acknowledge management responsibility in the risk policy (3.2)
Add a requirement to check for any new risks arising from the risk mitigation (6.6) and add a relevant column to the risk register