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MDSAP Internal Audits for Medical Device and IVD Companies

Companies selling devices in major markets – including Australia, Brazil, Canada, Japan, and the US – often take advantage of the Medical Device Single Audit Program (MDSAP). We help companies prepare for an upcoming MDSAP certification audit by the US FDA or another auditing organization.

How We Help

Are You Prepared to Meet the MDSAP Requirements?

MDSAP audits differ from a typical FDA inspection or Notified Body audit, in that the scope often extends well beyond your quality management system procedures and crosses over into regulatory compliance. It’s a meandering, process-based approach different from the checklist-based audits you may have experienced. It is not unusual for an MDSAP audit to be conducted by two auditors plus observers from member regulatory agencies. Preparing for this type of audit takes effort but is worth the time, since one successful audit satisfies numerous regulators !

Conducting an MDSAP Gap Audit

The first thing we do is determine your current compliance level against MDSAP requirements by conducting an MDSAP gap audit. We’ll follow the same approach that the auditing organizations (AO) will use and calculate your MDSAP audit score to identify your areas of biggest risk. This gives you time to plan and implement corrective actions and prepares you for what an actual AO certification audit will feel like. The gap audit concludes with a transition planning session. Since we are not an AO, we can make specific recommendations and give you an actionable roadmap to resolve any findings.

What We Do . . .

How We Do It . . .

  1. Perform a thorough review of your quality manual and standard operating procedures

Remote offsite

  1. Prepare an MDSAP internal audit plan, including who will be involved and the processes reviewed

Remote offsite

  1. Conduct an internal mock MDSAP audit, compile findings, and present them to the management team

Onsite at your facility (can also be remote)

  1. Draft a formal, detailed MDSAP audit report with your MDSAP audit scores and present clear recommendations for next steps

Remote offsite


An MDSAP Transition Action Plan Closes the Gaps

After we conduct your MDSAP gap audit, you have two choices: You and your team can implement our recommendations on your own, or you can bring us in to help. Additional support may include coaching to apply the risk-based approach , developing and reviewing MDSAP audit checklists, aligning your internal audits to the MDSAP process, assessing if your products are registered properly in the participating countries, and meeting the MDSAP adverse event and advisory notices reporting requirements. You should also consider our MDSAP auditor class or our MDSAP overview training class . Both are excellent ways to ensure that you and your staff are fully prepared for an MDSAP audit!

We’re Ready to Help

Oriel STAT A MATRIX specializes in helping medical device and IVD companies with QMS and regulatory compliance. Let us help you achieve a high score on your next MDSAP audit!

Provided below are a variety of practice related white papers, market updates and case studies.

Oriel STAT A MATRIX’s Goal

Help our life science customers meet regulatory requirements, boost efficiency, and improve patient outcomes

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