- Author
- MDRpilot Editorial Team
- Reviewer
- Independent regulatory review not yet assigned
- Last updated
- Applies to
- EU MDR 2017/745 Annex IX · ISO 13485:2016
Before the audit
- Confirm the audit plan, scope, sites and devices with the notified body
- Review findings from the last audit and confirm the related CAPAs are closed and effective
- Check the document register: all procedures approved, current revisions released, obsolete versions withdrawn
- Check that the PRRC is designated and their qualifications are documented
- Make sure critical suppliers and subcontractors are evaluated and under agreement
QMS records to have ready
| Area | Records |
|---|---|
| Management | Latest management review with inputs and outputs, quality objectives and their status |
| Competence | Training matrix, training records for key roles, job descriptions |
| Design | Design plans, reviews, verification and validation records, design changes |
| Purchasing | Approved supplier list, supplier evaluations, purchasing information |
| Production | Process validations, device history records, traceability, calibration |
| Feedback | Complaint log, vigilance reports, trend analysis, PMS data |
| Improvement | Internal audit reports, nonconforming product records, CAPA log with effectiveness checks |
Technical documentation checks
- Intended purpose identical in description, IFU, CER and risk file
- Classification rationale documented
- Every applicable GSPR row has a controlled evidence reference
- Every risk control has verification evidence
- CER is current and covers all claims; PMCF plan or justification is in place
- PMS plan is device-specific; PSUR or PMS report is current for the class
- Labels and IFU match the latest approved versions and carry UDI
On the day
- Assign a guide and a scribe for each auditor
- Retrieve documents quickly from the controlled system rather than from local copies
- Answer the question asked and show the evidence; do not speculate
- Record every observation and agree the wording of findings before the closing meeting
After the audit
Open a CAPA for each nonconformity, with root cause analysis, actions and a planned effectiveness check, and respond within the deadline agreed with the notified body. Use observations as input for the next internal audit.
How MDRpilot supports audit preparation
MDRpilot calculates an audit readiness score from technical file sections, GSPR evidence, QMS document status and CAPA status, lists the missing actions, and offers an audit simulator for MDR, ISO 13485, ISO 14971 or combined scope that records findings as major, minor, observation or positive. A high score means documents are in place; it does not predict the audit outcome.
References
- Regulation (EU) 2017/745 on medical devices (MDR) — EUR-Lex, Publications Office of the European Union.
- ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes — International Organization for Standardization.
- NANDO: notified bodies database — European Commission.
Always check the consolidated text of the regulation and the current version of each guidance document before relying on it.
This guide is general information about the regulation and standards named above. It is not legal or regulatory advice for a specific device.
MDRpilot is documentation and workflow software. It is not a medical device, not a notified body and not a regulatory authority. It does not certify devices or guarantee compliance; AI-generated drafts must be reviewed and approved by qualified people in the manufacturer's organisation.