ISO 13485 · Certification bodies
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.
We are a partner company of the Portuguese Institute for QualityReport 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(7.3) and corrective actions (8.5) generate most nonconformities, and common gaps are incomplete traceability matrices, outdated risk-management files and weak supplier controls.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.
How the review works
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.
Our 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.
What we check, by clause
Every 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.
- 4Quality management system and documentation
- 5Management responsibility
- 6Resource management
- 7Product realization, design (7.3) and suppliers (7.4)
- 8Measurement, analysis and improvement, with CAPA (8.5)
Anchored to the right references
From review to creating the report
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. One engine, many audit types.
The engine is yours. So is the client relationship.
Trust
Built for certification bodies in the EU.
EU data residency
Your clients' data stays in the EU.
GDPR-aligned
Handled to GDPR standards by default.
Isolated per auditor
Your reports never mix with another body's.
No model training
Your documents never train our models.
Unlimited users
Your whole team, no per-seat fees.
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.