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Medical Device Single Audit (MDSAP)

Meeting Global Compliance Requirements for Medical Device Manufacturers

The Medical Device Single Audit Program (MDSAP) is an international initiative that allows a recognized Auditing Organization to perform a single regulatory audit of a medical device manufacturer, fulfilling the applicable requirements of the participating regulatory authorities. A key benefit of the MDSAP is its ability to reduce the number of audits and inspections conducted by individual regulatory authorities across different target markets.
The MDSAP program standardizes how audits are performed on medical devices across countries. DEKRA, as an independent and recognized Auditing Organization under the Medical Device Single Audit Program (MDSAP), is well-positioned to provide these services.

Why Choose DEKRA for Auditing Medical Devices?

As a leader in medical device auditing, DEKRA offers expert-driven auditing services aligned with MDSAP standards across multiple jurisdictions. Here’s why DEKRA is a trusted choice for MDSAP audits:

MDSAP Benefits for Medical Device Manufacturers

Participating in the MDSAP program offers the following benefits:
  • Efficient Auditing Process: It enables a medical device manufacturer to undergo a single quality management system audit that meets the requirements of all participating regulatory authorities.
  • Access to Global Markets: MDSAP audits are accepted by regulatory authorities such as FDA, ANVISA, Health Canada, TGA, and PMDA, supporting market access in multiple regions.
  • The goal: is to streamline regulatory oversight by leveraging shared resources to create an efficient, sustainable single audit program, enhancing medical device safety while reducing industry burdens.

DEKRA’s MDSAP Auditing Services

DEKRA provides MDSAP auditing services for medical device manufacturers. Our audit teams are trained in the regulatory requirements for each participating jurisdiction. We conduct a focused Quality Management System audit to verify that your device meets the necessary MDSAP standards in the relevant markets.

Ready to Proceed With Your MDSAP Audit?

Contact DEKRA today to schedule your MDSAP audit and verify that your medical device meets global regulatory standards. With DEKRA, you can expect efficient, impartial, and audit-only services that are accepted worldwide. Contact us today!
FAQs
Is Medical Device Single Audit Program (MDSAP) mandatory?
How does MDSAP benefit manufacturers?
How can I schedule an MDSAP audit with DEKRA?