Regla
Regla provides an AI-native audit platform that runs ISO 13485 internal, mock, and full audits end to end, with certified auditors grading every finding. The platform reads up to 100% of a company's records, cites byte-exact evidence for each finding, and delivers pre-drafted corrective actions ready for adoption through existing change control processes.
- Regulatory & Compliance Technology
- Artificial Intelligence
- Software Only
Funding
Founders
Founder details are not available yet.
Product
Problem
Medical device manufacturers must maintain ISO 13485 certification through regular audits, yet traditional audits rely on sampling a small fraction of records and consume weeks of scarce senior team time. Notified body audits expect internal audits to have found problems first, so gaps in coverage put the certificate and market access at risk.
Solution
Regla provides an AI-native audit platform that runs internal, mock, and full ISO 13485 audits end to end, with certified auditors grading every finding. The platform reads up to 100% of a company's records—every procedure and record in scope—and cites byte-exact evidence from the company's own documentation for each finding. Every report is signed by an auditor of record, and findings are graded proportionately so minor matters remain minor. Corrective actions come pre-drafted with concrete proposal text, ready to adopt through existing change control processes. Audit plans are frozen before conduct begins, ensuring the audit measures the quality system against a standard set in advance. Deliverables include the audit report, management report, and session records conforming to the client's QMS templates.
Target Audience
Primary customers are medical device manufacturers that need ISO 13485 internal audits, mock audits before certification or notified-body audits, or full audits against every applicable requirement.
Features
- AI-native engine that reads up to 100% of records, with the option for classical sampled audits
- Byte-exact citations linking every finding to specific documents and clauses in the company's own records
- Certified auditors grade every finding proportionately in the register used by notified bodies
- Pre-drafted corrective action text ready for adoption through existing change control processes
- Preregistered audit plans that freeze before conduct begins, ensuring consistent measurement
- EU-resident infrastructure for data storage with full end-to-end EU processing available
- Deliverables signed by an auditor of record, including audit report, management report, and session records