Risk Requirements to meet the explicit Risk Based Approach of ISO 13485:2016 Examples

QE1993

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#21
Re: Risk Requirements to meet the explicit Risk Based Approach of ISO 13485:2016 Exam

Can someone help clarify:

ISO 13485:2016 is specifically referring to risk to the product, not necessarily risk to the QMS (although i recognize they can go hand-in-hand sometimes), correct?
 
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Sam Lazzara

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#22
Re: Risk Requirements to meet the explicit Risk Based Approach of ISO 13485:2016 Exam

See section 0.2 Clarification of concepts

When the term “risk” is used, it pertains to safety or performance
requirements of the medical device or meeting applicable regulatory
requirements.
 
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