Introduction
Medical device manufacturers selling in multiple countries face one common challenge, regulatory audits. The Medical Device Single Audit Program, known as MDSAP, was created to reduce that burden. One audit covers regulatory requirements for the US, Canada, Australia, Brazil, and Japan.
But passing an MDSAP audit is not easy. The audit is deep, structured, and unforgiving if your systems are weak. This guide walks you through a practical MDSAP audit checklist and shows how to prepare step by step for a successful outcome.
What Is an MDSAP Audit?
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An MDSAP audit evaluates whether your Quality Management System meets the regulatory requirements of participating countries. It is not just an ISO 13485 audit with extra questions.
The audit follows a strict sequence, starting from management processes and moving through design, production, and post market activities. Auditors use a process based approach, so missing links between processes often lead to nonconformities.
Why Preparation Matters
MDSAP audits leave very little room for correction during the audit itself. Auditors expect evidence to be ready, processes to be implemented, and staff to understand their roles.
Poor preparation can lead to:
- Major nonconformities
- Suspension or delay of market access
- Repeat audits and added costs
- Loss of confidence from regulators and partners
Good preparation turns the audit into a controlled review rather than a stressful event.
MDSAP Audit Checklist for Successful Preparation
1. Management Responsibility and Governance
Auditors start at the top. If management involvement is weak, the audit usually goes downhill fast.
Checklist items:
- Quality policy approved and communicated
- Management review conducted as per plan
- Clear quality objectives with measurable results
- Defined roles and responsibilities
- Evidence of regulatory awareness by top management
Tip: Management review minutes should show real decisions, not just formal notes.
2. Quality Management System Documentation
Your QMS must align with ISO 13485 and country specific requirements under MDSAP.
Checklist items:
- Quality manual aligned with MDSAP scope
- Controlled procedures and records
- Document control and change management
- Training records linked to roles
- Risk management integrated across processes
Tip: Auditors often check if procedures match actual practice. Gaps here are common findings.
3. Design and Development Controls
If your company handles design, this section carries high risk during an MDSAP audit.
Checklist items:
- Design and development procedure
- Design inputs and outputs documented
- Design review records
- Verification and validation evidence
- Design transfer records
- Design change control
Tip: Risk management files should clearly link to design decisions and validation results.
4. Supplier and Purchasing Controls
Supplier control is a major focus, especially for critical components and outsourced processes.
Checklist items:
- Approved supplier list
- Supplier evaluation and re evaluation criteria
- Supplier agreements and quality clauses
- Incoming inspection records
- Monitoring of supplier performance
Tip: If you outsource manufacturing or testing, expect deep questions and document reviews.
5. Production and Process Controls
Auditors verify that products are built consistently and under control.
Checklist items:
- Process flow diagrams
- Work instructions available at point of use
- Process validation where required
- Equipment calibration and maintenance
- Environmental controls, including cleanrooms if applicable
Tip: Operators may be interviewed. Training records must match actual tasks performed.
6. Labeling and Regulatory Compliance
Labeling errors can trigger serious nonconformities.
Checklist items:
- Label approval and control procedure
- Country specific labeling compliance
- UDI implementation where required
- IFU control and updates
- Traceability between product, label, and market
Tip: Ensure labeling matches the regulatory status in each MDSAP country.
7. Complaint Handling and Post Market Surveillance
This is one of the most heavily audited areas.
Checklist items:
- Complaint handling procedure
- Complaint records and investigations
- Adverse event reporting process
- Regulatory reporting timelines
- Trend analysis and feedback into risk management
Tip: Auditors look for closed loop systems, not just logged complaints.
8. Corrective and Preventive Actions (CAPA)
CAPA effectiveness often determines the final audit outcome.
Checklist items:
- CAPA procedure
- Root cause analysis records
- Defined actions with timelines
- Effectiveness checks
- Links to complaints, audits, and nonconformities
Tip: Weak root cause analysis is one of the most common MDSAP findings.
9. Internal Audits and Readiness Checks
You should audit yourself before the auditor does.
Checklist items:
- Internal audit program covering MDSAP scope
- Trained internal auditors
- Audit reports and follow ups
- Closure of previous findings
- Mock MDSAP audit if possible
Tip: Internal audits should follow the MDSAP process sequence, not just ISO clauses.
Common MDSAP Audit Mistakes to Avoid
- Treating MDSAP like a basic ISO audit
- Incomplete linkage between processes
- Poor training documentation
- Weak management involvement
- Unclear regulatory responsibility
Avoiding these mistakes alone can significantly improve your audit outcome.
Ready to Clear Your MDSAP Audit with Confidence?
How Operon Can Help You?
- MDSAP turnkey consulting support: Operon provides end-to-end MDSAP consulting, covering gap assessment, planning, implementation, and audit support.
- MDSAP gap analysis and readiness assessment: We perform a detailed gap analysis against the MDSAP audit model, ISO 13485, and country specific regulatory requirements.
- ISO 13485 Quality Management System implementation and optimization: Our team builds and strengthens ISO 13485 compliant QMS frameworks aligned with MDSAP expectations.
- CAPA and risk management strengthening: Operon helps improve CAPA systems, root cause analysis, and risk management integration; areas commonly flagged during MDSAP audits.
- Internal audits and mock MDSAP audits: We conduct internal audits and full scale mock MDSAP audits using the official audit sequence to prepare your team for real auditor interactions.
- Regulatory compliance support for multiple markets: Our experts help you align MDSAP compliance with US FDA, Health Canada, TGA, ANVISA, and PMDA requirements.
- On site and remote audit support: Operon supports you during the actual MDSAP audit, helping respond to auditor questions, manage evidence flow, and address observations effectively.
Ready to Clear Your MDSAP Audit with Confidence?
Get expert, hands on support from Operon Strategist to assess gaps, strengthen your QMS, and prepare your team for a successful MDSAP audit. Contact Operon Strategist today to discuss your MDSAP readiness and take the next step toward faster global regulatory approvals.
