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 . . . |
| Perform a thorough review of your quality manual and standard operating procedures | Remote offsite |
| Prepare an MDSAP internal audit plan, including who will be involved and the processes reviewed | Remote offsite |
| Conduct an internal mock MDSAP audit, compile findings, and present them to the management team | Onsite at your facility (can also be remote) |
| 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!
Related Downloads
Provided below are a variety of practice related white papers, market updates and case studies.
What is MDSAP (Medical Device Single Audit Program)?
What Is MDSAP?
At its core, MDSAP combines the requirements of ISO 13485:2016 with the national regulatory expectations of the participating countries which includes Australia, Brazil, Canada, Japan, and the US. The objective is to create a standardized and comprehensive audit process that meets the needs of multiple regulators. Unlike traditional models where each country conducts separate inspections, MDSAP allows approved Auditing Organizations (AOs) to carry out a single audit, resulting in a shared outcome that is accessible to all five regulators through a secure electronic portal.
Benefits of MDSAP
A major benefit of MDSAP is the streamlined auditing process it provides. Rather than facing multiple audits from different regulatory agencies, manufacturers are required to complete only one audit that satisfies the criteria of several countries.
This approach not only saves time but also cuts down on the costs associated with conducting various audits for different markets. With MDSAP, manufacturers can allocate their resources toward enhancing product quality and safety standards instead of spending excessive amounts on repetitive audits.
Additionally, another important advantage of adopting MDSAP is the expanded market access it offers. By participating in this program, manufacturers can enter five key international markets: the United States, Canada, Brazil, Australia, and Japan. This creates new opportunities for growing their customer base and accessing global markets more effectively.
How We Support Your MDSAP Readines
MDSAP audits are fundamentally different from FDA inspections or Notified Body evaluations. These audits go beyond simply checking documents; they adopt a process-focused, integrated approach that blends quality management and regulatory requirements. Instead of ticking boxes, auditors trace how your systems operate in practice and how well they interconnect. It’s also common for an MDSAP audit to involve multiple auditors and observers from various regulatory agencies. While this type of audit requires more effort to prepare for, the payoff is substantial—one successful MDSAP audit satisfies the demands of multiple regulators at once.
Performing an MDSAP Gap Audit
Considering the expenses and obligations associated with the MDSAP, it is essential to ensure readiness before the arrival of Auditing Organization (AO) auditors. One of the most effective strategies for preparing for the initial audit is to conduct a preliminary preparatory audit.
Ideally, this audit should be conducted by a knowledgeable third-party consultant who is well-versed in program requirements and regulatory expectations, and who has practical experience assisting other companies in their preparations.
In simple terms, MDSAP preparatory audits allow organizations to leverage the expertise of a third-party specialist to evaluate existing procedures and assess overall compliance. When discrepancies are found, these experts provide a clear roadmap for what needs to be done to achieve compliance, applying their findings across the entire quality system.
Bridging Compliance Gaps with an MDSAP Transition Action Plan
Once we’ve completed your MDSAP gap audit, you can either implement our recommendations in-house or enlist our support. If you choose the latter, we can assist with:
- Guiding your team to apply a tailored risk-based methodology aligned with MDSAP expectations.
- Creating and refining internal MDSAP audit checklists to ensure thorough and effective evaluations.
- Helping align your internal audit processes with MDSAP’s structure and sequence.
- Validating that your products are properly registered in all relevant MDSAP-participating jurisdictions.
- Ensuring you meet the requirements for reporting MDSAP adverse events and advisory notices.
To further strengthen your readiness, consider enrolling your team in either our MDSAP classes for ensuring full preparedness ahead of your MDSAP audit.