Medical-device QMS rebuild — ISO 13485 ready for notified body audit

−70%

Doc. cycle

−55%

Open CAPAs

−40%

Audit hrs

Document control used to consume two FTEs. With IMS Suite, version history, approvals and distribution are automatic — and every CAPA is linked to the failing requirement.
— Dr. A. Petrou, QA/RA Director, MedTek

The challenge

Legacy paper-based QMS with thousands of controlled documents, fragmented complaint handling, and an upcoming notified body re-certification.

What we built together

ISO 13485 clause library + complaint and CAPA workflow
Equipment register with calibration alerts
Multi-site SOPs distributed with read-and-understood tracking
Risk file linked to design controls and post-market surveillance

The outcome

Re-certification audit prep cut from 6 weeks to 3 weeks
Complaint cycle time reduced by 38%
Single source of truth across 3 production sites

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Medical-device QMS rebuild — ISO 13485 ready for notified body audit

The challenge

What we built together

The outcome

Could this be your team?

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