Internal-audit outsourcing

Why the internal audit matters

Every medical-device manufacturer must audit its own quality system every year. It is a condition of the certificate that lets it sell. The quality management system is the certified set of procedures for how every device is designed, made, and followed up: the thing the audit checks. Skipping or shortcutting the audit puts the certificate, and the product’s market access, at risk.

And the audit is not just a formality for your own benefit. A notified body, the external certifier, audits your company on top, and expects the internal audit to have found the problems first.

How the job is done today

• Your own quality team does it: weeks of scarce senior time, sampling a fraction of the records.
• Or consultants do it, billed by the hour, also sampling.
• Software tools only prepare. The audit itself stays human work.

What Regla does instead

Regla runs the audit itself: a full engagement executed end to end.

• As deep as you choose. A classical sampled audit, or the full record set read - every procedure, every record in scope. Both are real engagements; the depth is your scope call.
• Every claim traces to byte-exact cited evidence. A finding without evidence does not exist.
• Graded proportionately. A certified auditor grades every finding; minor matters stay minor, and observation-class matters stay observations. Depth never turns into busywork.
• The fixes come drafted. Findings arrive with concrete proposal text - down to the sentence for an SOP - ready to adopt through your own change control.

The audit plan freezes before conduct begins, like a preregistered study, so the audit measures your quality system against a standard set in advance.

Your external internal-audit function

Beyond a single engagement, Regla acts as your outsourced internal-audit function: the yearly audit planned, executed, and delivered on schedule, with the same independent third-party distance a notified body expects to see, and your senior people freed for the work only they can do.

Your data, EU-resident

Your records are stored on EU-resident infrastructure, read for the audit and for nothing else. Full end-to-end EU processing is available for every engagement.

What you receive

The complete deliverable set: the audit report with findings cited byte-exact into your own records, a management report with a concrete recommendation for every finding, and session records that conform to your own QMS templates - all signed by the auditor of record, with the fixes drafted and ready to adopt. Delivered in days.