Preparing for a Medical Device Single Audit Program (MDSAP) audit is a critical step for medical device manufacturers that aim to demonstrate compliance with multiple regulatory authorities through a single, harmonised audit process. For organisations selling products across different countries, MDSAP offers the benefit of reducing duplicate audits while ensuring that the Quality Management System (QMS) meets the stringent requirements of participating regulatory agencies.
The MDSAP Audit Approach Document No. MDSAP AU P0002.009, released on August 6, 2024, serves as the primary reference for understanding how these audits are conducted. This document details the structure, processes, and evaluation criteria auditors follow during an MDSAP audit, making it an essential resource for manufacturers preparing for this rigorous assessment.
This blog provides an in-depth guide to preparing for a successful MDSAP audit, covering both strategic planning and practical execution.
Understanding the MDSAP Audit Approach
The MDSAP audit is built on a process-based approach that aligns with ISO 13485:2016 requirements while incorporating additional jurisdiction-specific regulations. Instead of auditing clauses in isolation, auditors assess how processes interact and contribute to the overall effectiveness of the QMS.
The MDSAP audit focuses on seven key processes:
- Management
- Measurement, Analysis, and Improvement
- Design and Development
- Production and Service Controls
- Purchasing
- Device Marketing Authorisation and Facility Registration
- Medical Device Adverse Events and Advisory Notices Reporting
Each process is linked to specific audit tasks, questions, and evaluation criteria that must be addressed to demonstrate compliance with ISO 13485:2016 and the regulatory requirements of participating MDSAP countries, including the United States (FDA), Canada (Health Canada), Brazil (ANVISA), Japan (PMDA/MHLW), and Australia (TGA).
Step-by-Step Preparation Guide
A structured preparation plan is the most effective way to approach an MDSAP audit. The following seven-step approach can assist in aligning your QMS with MDSAP requirements.
1. Review the Latest MDSAP Audit Approach Document
Begin by thoroughly reviewing MDSAP AU P0002.009. This document lays out the audit sequence, the criteria for each process, and the specific questions auditors will use. Pay attention to jurisdiction-specific requirements that may apply differently depending on your target markets.
Tip: Keep a highlighted copy of the document accessible to your compliance and quality teams for quick reference during preparation.
2. Conduct a Comprehensive Gap Analysis
Perform a process-by-process comparison of your current QMS against MDSAP requirements. This should include:
- Reviewing documented procedures for each process
- Verifying the implementation of each procedure in practice
- Identifying where records, data, or evidence may be insufficient
- Mapping ISO 13485 clauses to MDSAP-specific audit tasks
Once gaps are identified, create a corrective action plan with clear responsibilities, timelines, and completion tracking.
3. Develop an Internal Audit Checklist Aligned with MDSAP
Your internal audit checklist should directly mirror MDSAP requirements. For each of the seven processes, include:
- Specific audit tasks listed in MDSAP AU P0002.009
- Evidence or records required for compliance
- Jurisdiction-specific points to verify
- Links to related ISO 13485 clauses for reference
This approach ensures your internal audit acts as a full rehearsal for the official audit.
4. Train Your Audit and Operational Teams
The effectiveness of your preparation depends on the competence and confidence of your staff. Training should cover:
- The MDSAP audit approach and its differences from standard ISO audits
- Process-based auditing principles
- How to respond to auditor questions with evidence-based answers
- The importance of maintaining composure and clarity during interviews
Mock audits are highly effective here, simulating the pressure of a real audit while providing an opportunity for immediate feedback and correction.
5. Strengthen Document Control and Record Management
One of the quickest ways to lose auditor confidence is missing, outdated, or inconsistent documentation. Ensure:
- All procedures, work instructions, and records are up to date and formally approved
- Document versions are clearly identified and controlled
- Records are easily retrievable and maintained in accordance with retention requirements
- Any obsolete documents are securely removed from active use
Remember: Auditors often start by assessing documentation before moving to on-site process observation.
6. Address Non-Conformities Proactively
Do not wait for the audit to highlight issues. Use your internal audits to detect potential non-conformities early and take corrective and preventive actions (CAPA). This demonstrates a culture of continuous improvement — a key point in MDSAP’s evaluation.
7. Engage in Ongoing Continuous Improvement
Preparation is not just a one-time exercise. Regularly use data from monitoring, measurement, and auditing activities to drive process improvements. A robust Plan-Do-Check-Act (PDCA) cycle embedded in your QMS ensures compliance and enhances efficiency.
Key Considerations for Each Process
While the preparation steps above apply generally, each MDSAP process has unique focus areas. Below are specific preparation tips for each:
1. Management
- Demonstrate top management commitment through active participation in QMS reviews and decisions.
- Ensure your quality policy and objectives are documented, measurable, and linked to strategic goals.
- Maintain management review minutes with documented follow-up actions.
2. Measurement, Analysis, and Improvement
- Implement strong data collection systems for product quality, customer complaints, and process performance.
- Use trend analysis to identify potential issues before they escalate.
- Show evidence of corrective actions leading to measurable improvement.
3. Design and Development
- Ensure design controls are clearly defined, including design input, output, verification, validation, and change control.
- Maintain a complete Design History File (DHF) that reflects the development journey from concept to market release.
- Be prepared to show examples of risk management activities integrated throughout the design process.
4. Production and Service Controls
- Have documented process validations for any process where output cannot be verified by subsequent inspection.
- Monitor environmental conditions affecting product quality, including cleanliness and contamination control.
- Ensure operators are trained and qualified for their assigned tasks.
5. Purchasing
- Evaluate suppliers based on their ability to meet your quality requirements, not just cost and delivery.
- Keep supplier performance metrics and re-evaluation records.
- Address supplier non-conformances promptly, documenting both investigation and corrective action.
6. Device Marketing Authorisation and Facility Registration
- Maintain an up-to-date inventory of regulatory licenses, approvals, and facility registrations for all jurisdictions.
- Ensure all authorisations are renewed before expiration.
- Keep copies of submissions and approvals in a central, easily accessible location.
7. Medical Device Adverse Events and Advisory Notices Reporting
- Have clear procedures for identifying, documenting, and reporting adverse events in each applicable market.
- Ensure timelines match regulatory authority requirements.
- Maintain records of any advisory notices, field safety corrective actions, and communications with regulators.
Common Pitfalls to Avoid in MDSAP Preparation
- Relying too heavily on ISO 13485 certification: while necessary, ISO compliance alone does not guarantee MDSAP readiness.
- Last-minute preparations: Auditors can easily detect when systems are patched together just before the audit.
- Overlooking jurisdiction-specific requirements: each MDSAP member has unique reporting, registration, or labelling rules.
- Poor communication during the audit: unclear, incomplete, or contradictory answers can undermine auditor confidence.
Conclusion
Preparing for an MDSAP audit is not just about passing an inspection — it is about building a QMS that is sustainable, compliant, and effective across multiple markets. By studying the MDSAP Audit Approach Document, conducting a rigorous gap analysis, training your teams, and focusing on process excellence, you can approach the audit with confidence.
A successful audit outcome strengthens your regulatory standing, improves operational efficiency, and ultimately enhances patient safety — the core objective of all medical device regulations.
Consistent preparation, proactive improvement, and a culture of quality will not only help you succeed in your next MDSAP audit but also maintain compliance year after year.
Reference
MDSAP AUDIT APPROACH (MDSAP AU P0002.009)
Author: Vijay Kureel
