ISO 13485 · MDR · MDSAP
ISO 13485 software for device records, CAPA and complaints.
Keep device production records, documents, CAPA and complaints connected.
Device History Records
Production records built at the station, reviewed by QA.
QMS Records Together
Documents, training, CAPA and complaints in one system.
Your QMS, your procedures
V5 supports the records; your team owns the quality system.
What goes wrong today3 common problems
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.
Everything V5 does here5 capabilities
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.
How it works, step by step5 steps
13485 lifecycle in V5 from design through post-market.
- Design Controls & DMR. Inputs, outputs, reviews, V&V under control.
- eDHR Templates Derived. Manufacturing records derived from DMR.
- eDHR Executed. Kiosk execution, exceptions gated, RBE.
- Complaints & PMS. Complaints feed risk and design changes.
What to look for when choosing
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
Does the DMR flow directly into eDHR templates and record structure? DMR-to-eDHR is one derivation; changes propagate under change control.
Risk file (ISO 14971) linkage
Are risk controls linked to design outputs, DHR steps and complaints? Risk controls addressable from design output through eDHR to complaint.
MDSAP-Ready Audit Exports
Can you produce MDSAP audit packs by jurisdiction and clause? MDSAP-ready exports by clause and jurisdiction.
Supplier Controls
Are supplier qualification, monitoring and audits in the same platform? Native supplier lifecycle with portal for evidence.
V5 Compared with Other Approaches
How V5 stacks up against a QMS-only tool with a separate MES/eDHR.
| capability | spreadsheet | legacy Qms | v5 |
|---|---|---|---|
| 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 | |
| N/A | Extra module | In-box | |
| Supplier portal | Optional | Native |
Regulations this supportsYour quality team stays responsible for compliance
13485 and MDR/QSR clauses that V5 answers directly.
ISO 13485 §4.1.6
Enterprise includes IQ/OQ and validation support; exact deliverables are set in your accepted quote/SoW. Your team plans, runs and approves intended-use validation and PQ as applicable.
ISO 13485 §7.3
Design controls modelled with reviews, verification, validation and design transfer artefacts.
EU MDR 2017/745 Annex I
GSPR mapped to design outputs, risk controls and test evidence within V5.
Standards Referenced
- 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
Common questions4 answers
- 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. IQ/OQ and validation support are included with Enterprise.