Service
Medical Device and IVD QMS
Build ISO 13485-aligned systems covering design control, traceability, calibration, supplier control, complaint/vigilance handling, storage, transport, and regulator-readiness mock audits.
Service environment
This service builds practical quality controls, documentation, routines, and decision points around the real manufacturing workflow so teams can sustain the system after implementation.
Factory line control
Inspection evidence
Audit documentation
Problems solved
- Traceability gaps
- Complaint handling weakness
- Supplier risk
- Storage and transport evidence gaps
Deliverables
- ISO 13485 gap review
- Traceability matrix
- Supplier controls
- Complaint/vigilance workflow
- Calibration controls
- Mock audit
Business impact
- Clarify ownership
- Create usable documentation
- Install operating discipline