Full ISO 13485 audits

Every clause, as deep as you choose

A notified-body audit covers the full standard but reads only what its sample reaches. Regla’s full ISO 13485 audit covers the full standard and goes as deep as you choose: a classical sampled examination, or everything in scope - every procedure, every record - with every finding citing byte-exact evidence from your own documentation.

Built to predict what a notified body will flag

The engine is calibrated on real audit outcomes. Every finding is graded by a certified auditor, proportionately: what matters is flagged at the weight it deserves, and no more.

Preregistered plan, the auditor’s signature

The audit plan freezes before conduct begins, like a preregistered study. A certified auditor grades every finding and signs every report as auditor of record.

Your data, EU-resident

Your records are stored on EU-resident infrastructure. Full end-to-end EU processing is available for every engagement.

What you receive

A full ISO 13485 audit report in the register a notified body uses: findings graded and cited byte-exact into your records, a management report with a concrete recommendation for every finding, session records conforming to your own QMS templates, and the fixes drafted, ready to adopt while they are still cheap. Signed by the auditor of record.