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How far is possible?

Written by Anders Emmerich on . Posted in Tips & Tricks.

We have been following an interesting discussion on Linked In "How far is possible"  (this link can only be viewed if you are a group member: Medical Devices: QA / RA discussion 'How far is possible?') as a result of the 14971:2012 Annex ZA deviation #3.

In this discussion, Mr. Singh linked to an informative presentation http://goo.gl/QJiUZj on the subject.

Most companies that participated in the discussion have updated their processes to avoid the term ALARP, usually also no longer identifying any 'Acceptable' ranges of risks. The driver seems rather be to comply with what notified bodies expect to see. All still acknowledge that there will always be the notion of an economical parameter when deciding on risk measures. The arguments backing why the risk measures weren't taken even further were recommended to be an analysis of Risk vs Benefit and claiming that the risk measures are 'State of the Art'

 

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