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.
What to look for when you're buying.
13485 systems must serve both the QMS and the shop floor — DMR, eDHR, complaints, CAPA, supplier and PMS on one record set. Bolt-ons cost you at every audit.
Design controls to eDHR linkage
What it tests: Does the DMR flow directly into eDHR templates and record structure?
Why it matters: Any gap requires reconciliation at every release.
V5: DMR-to-eDHR is one derivation; changes propagate under change control.
Risk file (ISO 14971) linkage
What it tests: Are risk controls linked to design outputs, DHR steps and complaints?
Why it matters: Otherwise risk file drifts and PMS cannot feed back.
V5: Risk controls addressable from design output through eDHR to complaint.
MDSAP-ready audit exports
What it tests: Can you produce MDSAP audit packs by jurisdiction and clause?
Why it matters: Prep for MDSAP is where legacy stacks burn months.
V5: MDSAP-ready exports by clause and jurisdiction.
EU MDR extensions
What it tests: Does the system carry UDI, EUDAMED payloads and PMS reports?
Why it matters: Two systems means two truths at inspection.
V5: UDI, EUDAMED payloads and PSUR/PMS derived in-system.
Supplier controls
What it tests: Are supplier qualification, monitoring and audits in the same platform?
Why it matters: Supplier gaps drive product findings.
V5: Native supplier lifecycle with portal for evidence.
Spreadsheet vs legacy QMS vs V5.
How V5 stacks up against a QMS-only tool with a separate MES/eDHR.
| Capability | Spreadsheet | Legacy QMS | V5 Ultimate |
|---|---|---|---|
| DMR → eDHR | Manual | Cross-tool integration | One derivation |
| Risk file linkage (14971) | Word file | Separate risk tool | Native, linked to controls |
| MDSAP packs | N/A | Consultant-assembled | One-click by clause |
| UDI & EUDAMED | N/A | Extra module | In-box |
| Supplier portal | Optional | Native |
The clauses, verbatim — and how V5 answers each.
13485 and MDR/QSR clauses that V5 answers directly.
The organization shall document procedures for the validation of the application of computer software used in the quality management system.
V5: Validation pack (IQ/OQ/PQ) delivered per release; per-tenant PQ under GAMP 5.
The organization shall document procedures for design and development.
V5: Design controls modelled with reviews, verification, validation and design transfer artefacts.
Each manufacturer of any class III or class II device... shall establish and maintain procedures to control the design of the device...
V5: Same design controls model serves QSR/QMSR.
General safety and performance requirements...
V5: GSPR mapped to design outputs, risk controls and test evidence within V5.
Step by step on the floor.
13485 lifecycle in V5 from design through post-market.
- 1Design
Design controls & DMR
Inputs, outputs, reviews, V&V under control.
- 2Transfer
eDHR templates derived
Manufacturing records derived from DMR.
- 3Make
eDHR executed
Kiosk execution, exceptions gated, RBE.
- 4Post-market
Complaints & PMS
Complaints feed risk and design changes.
- 5Audit
MDSAP / NB packs
One-click packs by clause and jurisdiction.
The math, with the assumptions visible.
13485 ROI comes from audit prep, DHR review time and PMS labour.
MDSAP prep labour
Packs derived from live records.
DHR review time
Review by exception.
PMS drafting
Live trend drives draft.
13485 programs typically fund V5 in the first audit cycle avoided of remediation.
What changed on the floor.
Setting
A Class II manufacturer moving from a bolted-together QMS + MES stack.
Before
MDSAP prep consumed 8 weeks per audit; DHR review 90 minutes per lot average.
After
MDSAP packs now derived in under 3 days; clean-lot DHR review under 10 minutes.
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.