The Medical Device Single Audit Program

MDSAP, or the Medical Device Single Audit Program, is a comprehensive certification that covers the regulatory requirements of the following markets:

  • USA
  • Canada
  • Brazil
  • Australia
  • Japan

EMMA International’s team of experts can help you throughout the entire MDSAP journey, including:

  • Perform a gap assessment to evaluate your audit readiness
  • Remediating identified gaps and weaknesses
  • Train and prepare your team
  • Respond to audit findings
  • Implement the necessary corrective actions

Steps to MDSAP Certification

Initial Audit

During Stage 1 of the initial audit, an auditor reviews documentation and evaluates your readiness for the Stage 2 audit. During Stage 2, an auditor determines whether your documentation meets all ISO 13485 and regulatory requirements. The auditor also evaluates your quality management system (QMS).

Surveillance Audit

Annual surveillance audits assure regulators that your documentation and QMS continue to meet all applicable ISO and regulatory requirements.

Recertification Audit

Every three years, the notified body will conduct a recertification audit, or re-audit. The recertification audit confirms continued relevance, suitability, applicability, and compliance of your QMS.

Unannounced Audits

If regulators suspect high-grade nonconformities, they may conduct an unannounced audit.

EMMA International assists through all audit stages. Connect with our team of experts to learn more.

Ready to learn more about working with us?

MDSAP Resources

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