Audit readiness
Audit readiness for MDR and ISO 13485 audits
Audit readiness is the state in which a manufacturer can show an auditor, without scrambling, that its QMS and device documentation are complete, current and supported by evidence. For MDR this applies to notified body QMS audits, technical documentation reviews and unannounced audits. MDRpilot measures readiness from the actual state of your workspace: technical file sections, GSPR evidence, QMS document status and open or overdue CAPAs. It lists the missing actions and lets you rehearse with an audit simulator before the real audit.
Who it is for
- Quality managers with an upcoming notified body audit
- Teams preparing for unannounced audits
- Consultants running pre-audits for clients
Key capabilities
Readiness score
Calculated from the real state of documents, evidence and CAPA.
Missing actions
Concrete list of what to fix, with links to the place to fix it.
Audit simulator
Question-and-answer rehearsal with graded findings.
Internal audit records
Plan and record internal audits as ISO 13485 clause 8.2.4 requires.
What drives the readiness score
- Technical file sections that are missing, in draft or approved
- GSPR rows without linked evidence
- QMS documents that are missing, unapproved or out of scope
- Open and overdue CAPAs
- Clause-level gaps against MDR and ISO 13485 requirements
Rehearsing with the audit simulator
The simulator asks audit-style questions for the scope you select (MDR, ISO 13485, ISO 14971 or combined) at quick, standard or full depth. Your answers are assessed and recorded as findings: major, minor, observation or positive. The output is a list of weaknesses you can turn into actions before the auditor finds them.
How the workflow runs
- 1
Check the score
See where you stand.
- 2
Fix the gaps
Work through the missing actions.
- 3
Rehearse
Run the simulator for the audit scope.
- 4
Close findings
Open CAPAs for real weaknesses.
Connected to the rest of the file
MDRpilot is not a stand-alone document generator. Requirements, evidence and documents share one product record.
Each step reads from the same product record. A test report linked to a GSPR row can verify a risk control, a change to the device class flags the documents that depend on it, and the audit readiness view counts what is still open across all of them.
Limitations
- The score measures documentation completeness, not the quality of your evidence.
- Simulator questions are a rehearsal aid; real auditors follow their own sampling and focus.
- A high score does not predict the outcome of a notified body audit.
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.
Frequently asked questions
Can MDRpilot help prepare for audits?
Yes. It shows a readiness score, lists missing actions across the technical file, QMS and CAPA, and offers an audit simulator for rehearsal.
What is an unannounced audit?
Notified bodies must carry out unannounced audits of manufacturers at least once every five years (MDR Annex IX, Section 3.4). Readiness therefore needs to be continuous, not a project before each planned audit.
Does a high readiness score mean we will pass?
No. It means the documents and records are in place. Whether they are adequate is judged by the auditor.
Which standards does the simulator cover?
MDR, ISO 13485, ISO 14971 and a combined scope. The quality manual wizard also supports ISO 9001.
Can we use MDRpilot for internal audits?
Yes. Internal audits are recorded as operational records, and findings can lead to CAPAs.
Related workflows
- MDR gap analysis that turns findings into actionsFind what is missing between your current documentation and EU MDR: GSPR evidence, clinical data, PMS, QMS procedures and change-related gaps, with clear next actions.Read more
- CAPA software that closes the loop with complaints, audits and riskRun corrective and preventive actions under ISO 13485 clause 8.5: sources, root cause, actions, effectiveness checks and links to complaints, audits and risk.Read more
- ISO 13485 software for quality manuals, procedures and controlled recordsBuild and run ISO 13485:2016 documentation: quality manual wizard, SOPs, forms, document control with review and approval, and a controlled document register.Read more
- Technical file software for MDR devicesBuild and maintain an MDR technical file per device: Annex II and III structure, section status, AI-assisted drafts, linked evidence and DOCX, PDF or ZIP export.Read more
- GSPR compliance with evidence you can traceMap every MDR Annex I General Safety and Performance Requirement to applicability, standards and evidence, and see which GSPR rows are still unsupported.Read more
Guides and resources
- MDR Audit Preparation ChecklistA practical checklist for notified body QMS audits and technical documentation reviews under the EU MDR, including unannounced audits, records to have ready and how to rehearse.Read more
- MDR Gap Analysis GuideHow to run an MDR gap analysis on a technical file and QMS: scope, inputs, a structured review by Annex, prioritisation of findings and turning gaps into a plan.Read more
- Medical Device CAPA GuideHow to run CAPA under ISO 13485 clause 8.5 and MDR: when to open a CAPA, root cause analysis, actions, verification, effectiveness checks and links to risk and PMS.Read more
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.
See it with your own device
Create an account, add your company and one real device. The Suite demo runs for 3 days and the first procedure opens straight away, not an empty dashboard.