ISO 13485 software for device manufacturers — from DMR to post-market.
V5 implements ISO 13485:2016 as an integrated QMS — design controls, DMR, eDHR, risk management hooks (ISO 14971), complaints with MDR decisioning, CAPA, supplier quality and post-market surveillance — on the same platform that runs the shop floor.
What breaks without this.
Design history, DMR and DHR live in three different systems
Audit prep takes weeks because nobody can reconcile them — and the Notified Body finds the gaps.
Risk file drifts from reality
ISO 14971 risk controls listed in the DMR but never linked to the actual production controls on the line.
Post-market signals don't reach design
Complaints, service events and field actions sit in customer service — never feeding the risk file or design changes.
Records-by-execution. Compliance, by design.
DMR and eDHR on one platform
Device master record links to the recipe, the components, the controls — and the device history record is generated from the production scans automatically.
Design controls with traceability matrix
User needs → design inputs → outputs → verification → validation, with every link recorded and exportable.
ISO 14971 risk hooks
Risk controls in the file are tied to the production controls on the floor — if a control is bypassed or removed, the risk file flags it.
Complaints with MDR decisioning
21 CFR 803 and EU MDR Article 87 decision trees built in, with rationale captured on every record.
MDSAP-ready evidence pack
Single set of records audit-ready for FDA, Health Canada, TGA, ANVISA and MHLW — exported as a structured inspector pack.
Proof points
- DMR, eDHR, design history file and risk file in one Part 11 audit trail
- ISO 14971 controls tied to live production controls
- MDR / EU MIR decisioning and export built in
- MDSAP inspector pack on demand
Built to satisfy
- ISO 13485:2016 (medical devices — QMS)
- ISO 14971 (risk management for medical devices)
- 21 CFR 820 (Quality System Regulation)
- EU MDR 2017/745 (Medical Device Regulation)
- 21 CFR Part 11 / EU Annex 11
Frequently asked questions
Is V5 a full ISO 13485 QMS?+
Yes — V5 covers all clauses relevant to a manufacturing QMS: document control (4.2), management responsibility (5), resource management (6), product realization (7) including design controls, and measurement/analysis/improvement (8) including CAPA, complaints and audit.
Does V5 generate the eDHR?+
Yes. The device history record is assembled from production scans, e-signatures and inline test results as the device is built — no separate documentation step.
Is V5 MDSAP-ready?+
Yes. One set of records satisfies FDA, Health Canada, TGA, ANVISA and MHLW evidence requirements, and the inspector pack exports in the MDSAP audit model structure.
How fast can we deploy?+
Standard ISO 13485 onboarding is 7–14 days depending on design-control migration scope. The validation pack (URS, FRS, IQ/OQ/PQ) ships with the platform.
See V5 on your own line.
Free trial, no card. Live in 7 days with guided onboarding.