A quality review on every ISO 13485 audit report.
Upload an ISO 13485 audit report and get an automated AI QA review against ISO 13485:2016, Clauses 4 to 8, with design controls and corrective actions (CAPA). Faster sign-off, consistent, reviewed and signed by you.
forauditsNorthgate CertificationReport review is the bottleneck before the certification decision.
ISO/IEC 17021-1 requires a competent person, not involved in the audit, to review the audit and its report before the decision. In medical devices the regulatory stakes are high: design controls (7.3) and corrective actions (8.5) generate most nonconformities, and common gaps are incomplete traceability matrices, outdated risk-management files and weak supplier controls. The reviewer must confirm every finding is tied to the most specific clause, properly evidenced, and that interrelated findings stay connected.
From report upload to a signed review.
Upload the report
Drop a finished or draft ISO 13485 audit report (PDF, DOCX or XLSX). foraudits validates it and starts the review.
forauditsNorthgate Certificationforauditsaudit-report.pdfOur AI engine reviews it
foraudits detects the standard and runs a structured pass over Clauses 4 to 8, with design controls (7.3), supplier controls (7.4) and corrective actions (8.5), evidence, consistency and completeness.
Reviewed report, with comments
You get the report annotated with comments, gaps and findings flagged in context. The decision and the sign-off stay yours.
forauditsreport-draft.docx
Reviewed by AI specialistEvery finding tied to the most specific clause.
With objective evidence and interrelated findings connected, and the distinction between correction and corrective action required by ISO/IEC 17021-1.
One engine, many audit types.
Once you are reviewing, we build the full flow for your standard: forms, checklists and the report. The same engine that reviews ISO 13485 reports also runs energy audits and NIS2 supply-chain compliance.
Built for certification bodies in the EU.
The engine is yours. So is the client relationship.
Questions about ISO 13485 report review.
- What is a ISO 13485 report checked against?
- ISO 13485:2016. That is the reference the report is checked against, clause by clause.
- What does the review check in a ISO 13485 report?
- Every finding is tied to the most specific clause. The review walks quality management system and documentation; management responsibility; resource management; product realization, design (7.3) and suppliers (7.4); measurement, analysis and improvement, with capa (8.5).
- Does foraudits change the report?
- No. The review returns findings and comments tied to the clause. The wording, the decisions and the signature stay with whoever runs the audit.
- Is foraudits a certification body?
- No. foraudits is not a certification body and is not accredited to certify, attest or verify. It reviews the report against the standard and returns the analysis; the decision and the signature stay with the competent body.
Let's review one of your ISO 13485 reports.
Book a demo and we'll review one of your ISO 13485 reports end to end.
foraudits is not an accredited certification body; the decision and signature belong to the reviewer.