Regla Information

Regla runs ISO 13485 audits for medical-device manufacturers: the yearly internal audit as an outsourced function, mock audits ahead of certification or surveillance, and full ISO 13485 audits. Every finding cites its evidence in the company's own records, graded in proportion to what it means for certification. The fixes come drafted, ready to adopt through the company's own change control, and the auditor of record signs every report. The work is done by ISO 13485-trained auditors and an AI engine that reads every record in scope. Depth is the company's choice: a classical sample, or every procedure and record in scope. Records are stored EU-resident, and full end-to-end EU processing is available for every engagement. Regla's research arm, the Regla AI Lab, publishes research in AI. regla.io - Talk to an auditor.