Internal-audit outsourcing
Your ISO 13485 internal-audit programme, run year-round by an independent team - findings cited, fixes drafted.
ISO 13485 - Medical devices
Audits that arrive with the fixes.
Regla runs your ISO 13485 audits - internal, mock, or full - with certified auditors and an AI-native engine built for total traceability. Findings cite their evidence in your own records, and the fixes come drafted, ready to adopt through your own change control.
- Independent certified auditors · a third-party audit function
- Built to read everything · up to 100% of your records
- Every finding cited · document and clause
- Fixes drafted · ready to adopt
A normal audit samples. Ours can read every single document.
- Weeks become days. A month of audit work, delivered in days, at a fraction of the cost.
- Nothing important missed. The engine can read the full record set - every CAPA, every complaint, every change - and every finding is graded proportionately.
- Findings arrive with fixes. Concrete, drafted proposals your team can adopt.
The auditor's stamp
Every finding cites byte-exact evidence in your own records and is graded by a certified auditor. Every report carries the signature of the auditor of record.
What we run
Mock audits
A full dress rehearsal before your certification or notified-body audit - findings you fix before anyone official sees them.
Full ISO 13485 audits
The complete audit, planned, conducted and reported end to end against every applicable requirement - with the fixes drafted.
Be audit-ready before anyone asks.
A 30-minute call with one of our certified auditors.
Talk to an auditor