Regulatory-grade supplier records, without the regulatory pain.
ISO 13485 compatible supplier quality management. Full traceability, supplier qualification records, and complaint handling for regulated medical products.
What medical devices quality teams wrestle with.
Regulatory traceability
MDR and FDA requirements demand complete traceability of components. You need systems that maintain an unbroken chain of documentation.
Supplier qualification
Qualifying new suppliers and maintaining qualification records is time-consuming. Notified bodies expect comprehensive supplier control evidence.
Complaint handling
Field complaints must be investigated promptly with clear root cause determination. Linking complaints to supplier issues requires good systems.
Built to address the medical devices reality.
Full traceability
Link supplier lots to incoming inspection records, NCRs, and CAPAs. Immutable audit trail provides the traceability regulators require.
Supplier qualification
Track supplier approval status, required certifications, and audit history. Document qualification decisions with supporting evidence.
CAPA management
Structured corrective action workflow with effectiveness verification. Link CAPAs to complaints and NCRs for complete investigation records.
Audit-ready records
Generate evidence packages for notified body audits. All supplier control records in one place, ready when auditors arrive.
In medical devices, the stakes are patient safety. Robust supplier control isn't optional — it's essential.
Aligned with the frameworks medical devices relies on.
- ISO 13485
- MDR (EU 2017/745)
- FDA 21 CFR 820
- ISO 9001:2015