ISO 13485 Software validation procedure and Quality Objectives Monitoring wanted

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yodon

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Several questions jump to mind before attempting an answer.

First, are you assuming the 2 are directly linked?

Next, are you talking about product software validation or software implementing some aspect of the QMS (which would require validation)?

Irrespective of the answers, it's rather unlikely that anyone else's validation procedures or quality objectives (or the monitoring thereof) would be suitable for your business. Software validation (either product or support software) is based on intended use and that will be unique to your product / the way you use applications. Similarly, quality objectives for your company need to be unique for your company's needs. Monitoring has a direct correlation to the measure being made.

If you're talking about medical device software validation, IEC 62304 is a harmonized standard in the EU and would be your best resource (although doesn't talk directly to "software validation").
 
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