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.