ISO 13485 software for medical-device makers who ship, not just certify.
Design controls with a live requirements-trace matrix, ISO 14971 risk file linked to software requirements per IEC 62304, CAPA / complaint / MDR tied to serial and lot, and execution on the same stack. ISO 13485:2016 and FDA QMSR (effective Feb 2026) evidence built by the system as work happens.
You're shopping for ISO 13485 software because your current setup was designed for documents, not for the manufacturer behind them.
Design controls, risk file and V&V evidence live in three different tools
CAPA takes 45 days to reach an approved plan, not close it out
Complaint records don't tie back to serial number and lot
Supplier quality is a spreadsheet of dates and a hope
FDA QMSR (2026) is coming and your QMS is still QSR-shaped
Post-market surveillance is a fire drill, not a report extract
ISO 13485 evidence, built by the system as work happens.
Design controls + DHF
Design inputs → outputs → V&V → transfer, threaded on a live requirements-trace matrix. The DHF is a report extract, not a manual compilation.
ISO 14971 risk file
Hazards, hazardous situations and harms with pre- and post-mitigation risk. Linked to software items per IEC 62304, to design outputs, and to eDHR in-process checks.
CAPA / NC / deviation on one graph
One relationship model. A CAPA is linked to the deviations that spawned it, the design change it drove, the training record it created and the effectiveness check that closed it.
Document control 7.5
Effective-date-aware document control with role-based training gating. Superseded revisions are provably unreachable at the workstation.
Training + competency 7.2
Training packages tied to job roles and effective document revisions. Non-current operators can't sign the step.
Supplier quality
Approved Supplier List, incoming inspection linked to supplier scorecard, SCAR workflow that ties back to the CAPA graph.
Complaint + MDR
Complaint intake, investigation, and MDR (21 CFR 803) / MIR (EU MDR Article 87) decision workflow with reporting-clock enforcement.
What changes when the QMS is native to the operation.
- Notified-body and FDA inspection prep collapses from weeks to hours
- CAPA cycle time drops meaningfully once the deviation graph is real
- Design-history-file compilation stops being a project
- Supplier scorecards become live, not annual
- FDA QMSR (2026) transition is a configuration exercise, not a re-architecture
- Post-market surveillance report is a query, not a spreadsheet
Every ISO 13485 clause an inspector will ask about.
ISO 9001:2015
Document control (7.5), competence (7.2), nonconformity & CAPA (10.2), internal audit (9.2), management review (9.3) — all modeled, all evidenced.
ISO 13485:2016
Design controls, DHF/DHR/DMR, risk management hooks (14971), CAPA, post-market — same engine, device-grade controls.
FDA QMSR (2026)
Aligned with the harmonized QSR/ISO 13485 final rule effective Feb 2026. Your QMS doesn't have to be re-architected — V5 is already there.
ISO 13485 software, answered.
What is ISO 13485 software?
ISO 13485 software is the system of record for a medical-device manufacturer's quality management system — design controls, DHF, risk management (ISO 14971), document control, training, CAPA, complaint, MDR reporting, supplier quality, post-market surveillance and internal audit — all threaded on one relationship graph and bound under 21 CFR Part 11 e-signature.
Does V5 support both ISO 13485:2016 and the FDA QMSR (2026)?
Yes. V5 is already aligned to the harmonized ISO 13485 / QSR final rule that becomes effective 2 February 2026. Customers using V5 today don't need to re-architect anything — the QMSR transition is a configuration exercise, not a project.
How does the risk file link to software?
ISO 14971 hazards, hazardous situations and harms are linked to design outputs and — for software items — to IEC 62304 software requirements, units and integration tests. A change to a software unit surfaces every risk-file entry it affects.
Does V5 handle CAPA, complaint and MDR?
Yes. Complaint intake, investigation, MDR (21 CFR 803) and MIR (EU MDR Article 87) decisions, CAPA linkage, effectiveness checks and post-market surveillance report generation all live on the same platform. Reporting clocks are tracked and gated.
Does V5 replace a document control system?
Yes. Effective-date-aware document control with role-based training gating is native. Superseded revisions are provably unreachable at the workstation, and training compliance is a hard gate for signing eDHR steps.
How long does implementation take?
Most device manufacturers run their first signed CAPA and controlled document within 21–30 days of kickoff. Full QMS rollouts including design controls, supplier quality and post-market surveillance typically take 8–14 weeks.
Run ISO 13485 as an operating model, not a documentation project.
Free trial. Real design-control workflow. No sales gate.