foraudits
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.

Book a demoHow it works
Clauses 4 to 8
reviewed on every report
Minutes
instead of a manual read-through
Consistent
the same QA pass every time
forauditsVértice Certificação
relatorio-auditoria.pdf
Standard detectedISO 13485:2016
7.3design controls
8.5.2corrective actions (CAPA)
7.4supplier controls
Partner firm of the Portuguese Quality Institute

Report 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(7.3) and corrective actions (8.5) generate most nonconformities, and common gaps are incomplete traceability matrices, outdated risk-management files and weak supplier controls.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.

01

Upload the report

Drop a finished or draft ISO 13485 audit report (PDF, DOCX or XLSX). foraudits validates it and starts the review.

forauditsVértice Certificação
Upload report
Drop your draft reportPDF · DOCX · XLSX · up to 50 MB
rascunho-relatorio.docxValidated
forauditsrelatorio-auditoria.pdf
Standard detectedISO 13485:2016
7.3design controls
8.5.2corrective actions (CAPA)
7.4supplier controls
02

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.

03

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.

forauditsrascunho-relatorio.docx
Reviewed by AI specialist
ISO 13485:2016
7.3.9
traceability matrix incomplete
7.1
risk management covered
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
ISO 13485:2016ISO/IEC 17021-1MDSAPFDA QMSR (21 CFR 820)EU MDR 2017/745ISO 14971Independent certification decision
From review to creating the report

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.

Energy auditsSupply-chain NIS2
Trust

Built for certification bodies in the EU.

The engine is yours. So is the client relationship.

EU data residency
Storage and processing in the European Union, including AI review.
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.

Book a demo

foraudits is not an accredited certification body; the decision and signature belong to the reviewer.