ISO 13485:2016 · FDA QMSR · Design Controls · Risk · CAPA · Post-market
ISO 13485 software for medical-device makers, from design controls to the shop floor.
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.
Design Controls + DHF
ISO 14971 Risk File
CAPA / NC / Deviation on One Graph
Document control 7.5
Full product detailCommon problems, what's included, why teams choose it, and where commercial meets regulated.
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
Complaint records don't tie back to serial number and lot
Supplier quality is a spreadsheet of dates and a hope
FDA QMSR took effect on 2 February 2026 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 Superseded revisions are provably unreachable at the workstation.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.
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's QMS workflows are organised around ISO 13485:2016 and the FDA QMSR, which incorporates ISO 13485 by reference and became effective on 2 February 2026. Your own procedures, validation and records still determine compliance.
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.
Does V5 replace a document control system?
Yes. Effective-date-aware document control with role-based training gating is native.
Capabilities vary by plan and setup. Confirm specifics with our team before relying on them.
Run ISO 13485 as an operating model, not a documentation project.
Free trial. Real design-control workflow.