Why Audit Preparation Matters
Under MDR and ISO 13485, regular audits by notified bodies or internal teams ensure that medical devices are safe, effective, and compliant. Being ready for common audit questions not only prevents non-conformities but also builds confidence with regulators and customers.
Common Audit Questions You Should Expect
1. Quality Management System (QMS)
- Can you demonstrate compliance with ISO 13485?
- How do you document processes and responsibilities?
- How often do you review and update your QMS?
2. Risk Management
- How is ISO 14971 applied in your risk assessment?
- Can you show a risk management file for this device?
- What controls are in place for residual risks?
3. Technical Documentation
- Do you have up-to-date technical files?
- How do you ensure traceability between design, risks, and clinical data?
- Can you provide labeling and IFU (Instructions for Use)?
4. Post-Market Surveillance (PMS)
- What systems are in place to collect real-world performance data?
- How do you conduct Post-Market Clinical Follow-up (PMCF)?
- How do you report adverse events?
5. Corrective and Preventive Actions (CAPA)
- Can you show recent CAPA reports?
- How do you ensure non-conformities are corrected?
- How are preventive actions documented and monitored?
6. Employee Training and Awareness
- How do you train employees on MDR and QMS requirements?
- Are staff aware of their compliance responsibilities?
Tips to Handle Audit Questions Successfully
- Answer Clearly and Honestly: Don’t overcomplicate responses.
- Have Documentation Ready: Every claim should be backed by records.
- Train Staff: Make sure all departments understand their roles.
- Conduct Mock Audits: Simulate questions to boost confidence.
- Stay Calm: Auditors look for consistency, not perfection.
Conclusion
Audits don’t have to be intimidating. By preparing for common questions and keeping documentation up to date, medical device companies can transform audits into a showcase of their commitment to safety and quality.
