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How does the Medical Device Single Audit Program Fit With ISO 13485? Is This Just an Emerging Program?

This emerged back in 2012 with IMDRF. The FDA adopted it in 2014 and it can be found on their website. It states that for the Medical Device Single Audit Program they are willing to accept audit reports as a suitable supplement for routine agency inspection. The full implementation of this vision is still evolving. It seems to be more focused on ISO 13485 2016 standard and some of the new case for quality might be out prioritizing this MDSAP. If you consider the FDA’s compliance and inspection strategy they have always had a scalable approach. In the past, it has been based more on a firm’s historical EIR experience and they would use that to determine the frequency of inspections. This would determine whether an abbreviated inspection or full inspection would be given, and how often they would come out. The latest case for quality initiative is a part of their evolving vision. It does not seem as though this has reached its full implementation state at this point. On the FDA’s website there are some testimonials about how this has helped companies to decrease the number of audits that they have done and harmonize between ISO 13485 and this MDSAP. The participants, aside from the US, Australia, Brazil, Canada, and Japan, the world health organization and EU are observers right now. That might be attributing to the delay. However, based on what's on the FDA website, looks like it got some momentum and that they're looking at this program to roll out in 2017 or 18.

USDM Life Sciences leverages an experienced delivery team, proven methodologies, and best practices validation documentation to provide our life science customers a rapid, cost-effective approach to implementing, configuring, validating, integrating and supporting your QMS.


  • Clintrak - Jeffrey D. Coffin
    I have had the great pleasure to work with Bob for 5 years in his position of VP of Quality at Fisher Packaging Services while I acted as Director of Quality services at a sister…
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