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An insight into the Medical Devices Single Audit Program (MDSAP) from Jane Oglesby

MDSAP vision:

“To develop, manage and oversee a single audit program that will allow a single regulatory audit to satisfy the needs of multiple regulatory jurisdictions." (MDSAP P0001.002)

If you sell medical devices into Canada, you will no doubt be familiar with the MDSAP. If you sell into any of the other five participating jurisdictions of Australia, Brazil, Japan, or the USA, you will probably have heard of the MDSAP and be considering whether or not to apply for an MDSAP audit as there are both advantages and disadvantages of being part of the Medical Devices Single Audit Program.

In order to try and achieve the MDSAP Vision, auditing organisations have been authorised to conduct MDSAP audits covering the QMS requirements of all five participating jurisdictions. Their audit reports are shared with the regulatory authorities of participating jurisdictions but not subject to freedom of information. In other words, the FDA will have access to the report and non-conformities - however, your competitors will not. This is perceived as a big advantage for many organisations.

The requirements are detailed in the MDSAP Companion Documents, and although derived from ISO13485:2016, there are significant differences in the execution of a typical ISO13485 audit and MDSAP audit.

Don’t make the mistake of thinking that the MDSAP is just ISO13485 with a few extra reference to regulations.

Do prepare for each MDSAP audit - use the companion document, ensure competence in MDSAP is documented, conduct a gap analysis/internal audit, add details to procedures, understand the grading system, and above all - avoid expensive unannounced audits.

The article was written by Jane Oglesby, a Medical Devices Specialist at Oglesby MDS Limited, Medilink member.

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