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Internal Audit Program under MDSAP and 13485:2016
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Internal Audit Program under MDSAP and 13485:2016
Internal Audit Program under MDSAP and 13485:2016
Internal Audit Program under MDSAP and 13485:2016
Internal Audit Program under MDSAP and 13485:2016
Internal Audit Program under MDSAP and 13485:2016
Internal Audit Program under MDSAP and 13485:2016
Internal Audit Program under MDSAP and 13485:2016
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internal audits, iso 13485:2016, mdsap (medical device single audit program)
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  Post Number #9  
Old 11th December 2017, 02:39 PM
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Total Posts: 47
Re: Internal Audit Program under MDSAP and 13485:2016

Quote:
MDSAP doesn’t require regulatory compliance in domains where the audited org doesn’t distribute.
Hi Ronen,

It does not require (audit findings are not raised as NCs), but they are reported. "Single" audit means that the audit is not different depending on your specific markets, it is always the same audit. For that reason I find MDSAP more inclusive, however I do agree that all you ever need to prepare for is ISO 13485. Preparing for MDSAP only removes the element of surprise from the audit.

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