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