Medical-device QA/RA Manager — every DHR defensible, every submission ready.
You are accountable for ISO 13485, 21 CFR 820 (QMSR after February 2026), MDR / IVDR, IEC 62304 and IEC 14971 evidence — often at the same time, for the same device family, in front of different notified bodies and FDA. V5 is one platform where the DHF stays linked to the DMR, the DMR drives the routing on the line, the eDHR self-builds per serial, and CAPA / complaint / MDR reporting close the loop back into the DHF. When the auditor arrives, the submission pack builds itself.
The 5 problems we hear from every Medical-Device QA/RA Manager.
DHF, DMR and DHR live in three different systems — every audit turns into a reconciliation project.
DHF (design controls + RTM), DMR (routing + BOM + specs) and DHR (per-serial as-built) are the same object model in V5. Change a design output, the DMR flags the affected routing, the eDHR captures the new revision on the next serial.
Design changes reach the floor before training is re-issued.
Design-controls change control triggers a document-control revision and a training re-issue in one workflow. Operators cannot start a step on the new revision until the new training is signed.
MDR / MDR EU vigilance clocks slip because complaints land in email.
Public complaints portal per tenant → AI-drafted investigation → structured MDR / EU Vigilance clock started at intake → traceable link to the serial, DHR and DMR revision behind the complaint. Two-sig closure per 21 CFR 820.198.
IEC 62304 SOUP and anomalies live in a separate ALM tool.
Software items, SOUP register, verification / integration / system tests and anomalies are part of the same RTM. The same requirement that gates release is the row an auditor asks about.
510(k) or MDR submission pack takes weeks to assemble each time.
Submission Readiness assembles DHF, ISO 14971 risk file, RTM, verification / validation summaries, DHR sampling, CAPA history and complaint trending in one signed PDF pack. Regenerate on demand for each submission.
What changes Monday morning.
Open the QMS home — see today's open complaints with clock status, overdue CAPAs, MDR reportability decisions waiting on sign-off, design changes in review, and any DHR held for exception. Click 'submission readiness' before a notified-body meeting; the pack builds in minutes with DHF, RTM, risk file, DHR sampling and CAPA history in one signed PDF.
What the numbers look like.
| Metric | Before | With V5 |
|---|---|---|
| Submission pack build time | 2–4 weeks per submission | Same day, one click |
| MDR / EU Vigilance clock on-time rate | 70–85% | 98%+ with intake-triggered clocks |
| DHR review-to-release | 2–5 days per serial batch | Same shift |
| Design-change-to-training-re-issue gap | Days to weeks | Same workflow, zero gap |
The modules that matter for your role.
Quality management
Part 11-by-construction records across DHF, DMR, DHR, CAPA, complaint and change.
Document control
DHF-linked SOPs, work instructions and specifications with training binding.
Audits & CAPA
Auto-escalation, effectiveness checks, two-sig closure tied to serial and DHR.
Supplier quality
Structured supplier docs, expiry tracking, signed acknowledgements tied to lot receipt.
eDHR
Per-serial device history — built as the operator works, locked at final inspection.
Compliance self-assessment
Score against ISO 13485, 21 CFR 820 / QMSR, MDR, IEC 62304 and IEC 14971 on demand.
Questions Medical-Device QA/RA Managers ask us.
Does V5 support QMSR (the February 2026 update to 21 CFR 820)?+
Yes — V5's QMS module is aligned to QMSR terminology and structure, and the compliance self-assessment scores against both the legacy 820 and the new QMSR clause map so a mid-transition manufacturer can see gap and evidence in one view.
How does V5 handle IEC 62304 software of a medical device?+
Software items, architecture, unit / integration / system tests, SOUP register and anomalies are part of the same RTM as the mechanical requirements. If your device includes SaMD, the software evidence sits inside the same DHF and submission pack — no separate ALM to reconcile.
Can we keep using Greenlight or Matrix for design controls and just use V5 for the floor?+
Yes — V5 exposes REST + webhook contracts and this is a common transition pattern. Most customers consolidate on the next audit cycle because the double-source reconciliation is what caused the original problem.
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