Medical devices
ISO 13485, EU MDR, UDI, and FDA QMSR — quality systems that hold up under inspection.
Map a control once. Cite it everywhere.
What teams do with Traceage
Every card is a real job, framed for the person who owns it.
QMS Manager
ISO 13485 & FDA QMSR readiness
A living quality system — design controls, NCRs, and CAPA on one audited trail.
Regulatory Affairs
UDI & EU MDR submissions
Unique Device Identification and MDR technical files generated from existing records.
Complaint Handling Lead
Field-failure traceback
Trace a complaint to the lot, line, and components that produced it — in minutes.
Post-Market Surveillance Lead
Vigilance signal detection
Aggregate complaints, returns, and field data into signals before they become recalls.
Supplier Quality Engineer
Component conformity
Tie every critical component to its supplier's certificate of conformity and qualification status.
Manufacturing Engineer
Device History Records
Assemble a complete, inspection-ready Device History Record from line events automatically.
Every stage on one continuous record.
The medical devicesworkflow — and where Traceage fits at each step.
- 01
Design controls
Design history and risk files maintained as a living record.
- 02
Source components
Critical components tied to supplier conformity and qualification status.
- 03
Manufacture & UDI
Device History Records built from line events; UDI applied per unit.
- 04
Distribute
Each device serial tracked through distribution to its destination.
- 05
Post-market surveillance
Complaints and field data aggregated into vigilance signals.
What it delivers.
Proof of authenticity & quality
Every device tied to its Device History Record and UDI.
Verified ethical & sustainable sourcing
Critical components traced to conformity-certified suppliers.
Real-time visibility & convenience
Hospitals and distributors verify a device's provenance instantly.
Fast, painless issue resolution
A field failure traces to its lot, line, and components in minutes.
The regulations, in plain terms.
Every framework Traceage maps for medical devices.
- FDA QMSR
- US FDA Quality Management System Regulation — replaced 21 CFR 820 in 2026, harmonising US rules with ISO 13485.
- ISO 13485
- The international quality-management standard for the design and manufacture of medical devices.
- EU MDR
- EU Medical Device Regulation 2017/745 — safety, performance, and traceability requirements for devices.
- EU IVDR
- EU In-Vitro Diagnostic Regulation 2017/746 — equivalent requirements for diagnostic devices.
- MDSAP
- Medical Device Single Audit Program — one audit recognised across the US, EU, Canada, Brazil, Australia, and Japan.
See it on your own data.
Stand up a working setup in days. No rip-and-replace.