The Regla ISO 13485 audit, explained in 80 seconds

Narration: AI-generated.

Regla runs ISO 13485 audits for medical-device companies - internal, mock, or full - with certified auditors and an AI-native engine built for total traceability.

Talk to an auditor How an audit runs

Chapters

  1. 0:00 Regla - audits that arrive with the fixes
  2. 0:04 The mandatory audit costs weeks - and samples
  3. 0:14 Certified auditors on an AI-native platform
  4. 0:22 How it works - five steps
  5. 0:48 A complete internal audit in days
  6. 1:00 Three ways in
  7. 1:13 Be audit-ready before anyone asks

Transcript

0:00 Regla - audits that arrive with the fixes.

0:04 The mandatory ISO 13485 audit costs weeks of scarce senior time, every year - and however it is run, it samples a fraction of your records.

0:14 Regla runs your audits with certified auditors on an AI-native platform - one that can read every single record, so nothing important gets missed.

0:22 Your records are extracted into one auditable place, on EU-resident infrastructure.

0:28 The engine reads them - and every claim cites verbatim evidence in your own documentation.

0:34 A certified auditor grades every finding, proportionately.

0:38 The report lands in your QMS's own templates, signed by the auditor of record.

0:43 And the findings arrive with the fixes drafted - ready for your own change control.

0:48 A complete ISO 13485 internal audit, delivered in days rather than weeks - a full report with a session record per unit, machine-verified end to end, and signed by the auditor of record.

1:00 Three ways in: your internal-audit programme, run for you year-round. The mock audit - the dress rehearsal before the audit that counts. And the full ISO 13485 audit - every clause, up to every record.

1:13 Regla. Be audit-ready before anyone asks.