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Hello Forum,
I have done Rsik management for a medical device here in Germany with the definition
of Risk acceptance Matrix shown below.
In accordance to 14971 I can define the ALARP (yellow) by my self. It depends on
the device and what makes sense. What restriction (soft and hard) are there in general?
greetings
Florian Hillen
I have done Rsik management for a medical device here in Germany with the definition
of Risk acceptance Matrix shown below.
In accordance to 14971 I can define the ALARP (yellow) by my self. It depends on
the device and what makes sense. What restriction (soft and hard) are there in general?
greetings
Florian Hillen
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