Medical Device Single Audit Program (MDSAP)
We help you prepare for the MDSAP audit program. We perform GAP asessments, and help implement MDSAP compliant procedures.
Why MDSAP Audits are both an opportunity and a challenge
Why MDSAP Audits are both an opportunity and a challenge
The Medical Device Single Audit Program (MDSAP) allows manufacturers to undergo a single audit recognized by multiple countries and their major regulatory authorities. These include the U.S. FDA, Health Canada, TGA (Australia), PMDA (Japan), and ANVISA (Brazil). This unified approach eliminates redundant audits and accelerates market entry.
The MDSAP audit model demands precise QMS integration and alignment with ISO 13485:2016 and each participating country’s regulatory requirements. Many companies underestimate the preparation, resulting in unexpected nonconformities. A negative MDSAP report may trigger “for cause” inspections by regulatory authorities, adding further scrutiny and potential disruption to operations.We help you prepare. Our MDSAP auditors are experienced in simulating a MDSAP audit. They identify blind spots in your QMS and ensure your organization is fully prepared—whether it's your first MDSAP audit or a recurring one.
Satisfied Clients
Our MDSAP Audit Services:
MDSAP Readiness Assessment
In a desktop review, we evaluate your existing QMS against MDSAP requirements, identify compliance gaps, define areas of improvement, and provide a clear roadmap toward audit readiness.
MDSAP training
We train your teams on the MDSAP approach and country specific requirements based on your training needs. This can be instructor led or e-learning and ensure the training effectiveness is evaluated.
Mock MDSAP Audits
We simulate the structure, rigor, and documentation flow of an actual MDSAP audit, ensuring your team gets familiar with the MDSAP audit approach, audit your processes, and ensure full preparedness.
QMS Integration Support
We help harmonize your existing ISO 13485 QMS framework with MDSAP’s country-specific expectations (FDA QSR, Health Canada, TGA, PMDA, ANVISA) for seamless alignment.
Audit Follow-Up and CAPA Management
We assist in interpreting findings, creating a corrective action plan and implementing corrective actions.
Our approach combines comprehensive MDSAP audit preparation, mock-audits and hands-on training—so your team is ready and well prepared before the MDSAP auditors arrive.
A strong MDSAP result enhances your reputation among regulators, customers, and partners while conveying a commitment to quality and global compliance.
Couldn't find your question?
What is the main benefit of MDSAP certification?
MDSAP allows one audit to satisfy the regulatory requirements of multiple major markets, significantly reducing the number of separate audits you must undergo.
How long does MDSAP preparation typically take?
Depending on the maturity of your QMS, preparation may take from a few weeks for ISO-compliant systems to several months for new or transitioning organizations.
What is the difference between ISO 13485 and MDSAP?
While ISO 13485 provides the base framework, MDSAP adds regulatory-specific requirements from participating countries, making it more comprehensive.
Can you help us address findings from a previous MDSAP audit?
Yes. Our experts can analyze audit reports, design CAPA plans, implement corrective measures, and liaise with your auditing organization for effective closure.