Case Study
Supporting ISO 13485 readiness for a medical device distributor
Medical device distributorMedical Devices and Healthcare ProductsDiagnose, Design, Document, Deploy
Case evidence
Challenge
Traceability, complaint handling, supplier records, calibration, and storage evidence were inconsistent.
Solution
Built ISO 13485-aligned workflows for traceability, supplier control, vigilance, storage, and mock audit readiness.
Results
The distributor gained stronger regulator readiness and clearer customer approval evidence.
What changed
Traceability matrix created
Complaint workflow defined
Mock audit checklist completed