Is QMS Nordic a validated QMS?

QMS Nordic's workflow gates are structurally enforced — you cannot close a CAPA without §820.100(a)(4) effectiveness verification. Validation evidence (IQ/OQ/PQ) is generated for Enterprise customers as part of onboarding.

Which regulations does QMS Nordic cover?

EU MDR 2017/745, EU IVDR 2017/746, FDA QMSR / 21 CFR Part 820, FDA 21 CFR §803 (MDR), 21 CFR Part 11, ISO 13485:2016, ISO 14971:2019, IEC 62304, IEC 62366-1, EU Annex 11, GDPR, MDSAP, UKCA, PMDA, ANVISA, NMPA, TGA, Swissmedic.

Can QMS Nordic produce a regulator-ready submission?

Yes. The Submission Packager ships templates for FDA 510(k), EU MDR Technical Documentation (Annex II + III), IVDR Performance Evaluation, MDSAP, UKCA, PMDA, ANVISA, NMPA, TGA. Each export includes an MDR Annex IX manufacturer-of-record block and the full audit trail.

Does QMS Nordic support Post-Market Clinical Follow-up (PMCF)?

Yes. PMCF plans (EU MDR Annex XIV Part B §6) are AI-populated from PubMed, Cochrane, ClinicalTrials.gov, FDA MAUDE, EUDAMED, and other regulator registries — every section approved/edited/rejected by a human before activation. Periodic PMCF evaluations feed directly into the PSUR.

How is the AI safe to use in a regulated context?

AI-generated content is labelled, retained alongside the human decision, never auto-approved, and uses only well-known regulatory + scientific registries (PubMed, FDA, EUDAMED, EMA, MHRA, etc.) — no random web pages. Every AI run is hash-logged for EU AI Act + 21 CFR Part 11 traceability.

What happens at end of trial?

On day 31 your tenant automatically converts to the Starter Growth plan ($849/mo annual or $999/mo monthly). Cancel any time. No data is deleted on plan change.

MDR · IVDR · QMSR · ISO 13485 · IEC 62304 · Part 11

Inspection-ready, every single day.

The AI-native QMS for life-science companies. Thirty integrated modules, AI auto-populate restricted to trusted regulator + scientific registries (PubMed, MAUDE, EUDAMED, EMA, MHRA, NVD), and a Submission Packager that bundles your evidence into a regulator-ready file for FDA, EU MDR, IVDR, MDSAP, UKCA, PMDA and more — in one click.

Start 30-day free trial See how it works

Full feature access · No credit card · Cancel anytime

30+

QMS modules

Submission templates

100%

Audit-chain coverage

< 5 min

Tenant spin-up

Audit-chain verified

AI Copilot active

QMS Nordic.app/dashboard

CAPA cycle

−18%

Open audits

0 overdue

MDR clocks

all green

Submission %

+6 this wk

FDA 510(k) — Wearable Pulse Oximeter

READY 94%

DeviceRiskSW lifecycleUsabilityClinicalLabeling

Recent CAPA activity

live

CAPA-204Caster wear failure-mode reviewEffectiveness

CAPA-203Supplier audit non-conformanceCA / PA

CAPA-202Sterilization log gapClosed

Stop assembling QMS evidence the night before an inspection.

QMS Nordic makes the four most-cited audit findings structurally impossible.

CAPA backlogs that close the night before an FDA visit

Six-phase workflow with §820.100(a)(4) effectiveness gate — closure is structurally impossible without verified evidence.

Missing the EU MDR 10-day clock because nobody knew it started

Reportability is computed from the awareness date the moment a complaint is logged. EU + FDA + MHRA + PMDA + ANVISA deadlines surfaced on the dashboard with red countdowns.

510(k) submission day arrives and the binder is in 14 different folders

Submission Packager pre-creates the canonical TOC for FDA 510(k), EU MDR TD, IVDR PE bundle, MDSAP, UKCA, PMDA, ANVISA, NMPA and TGA. Pin evidence from any QMS module; completeness scored in real time.

Inspectors asking for a CAPA + you scramble to print it

Audit-ready PDF on every record with the MDR Annex IX manufacturer block, full audit trail, and signature lines pre-laid out.

Built for the regulations as written.

Every obligation in the rule pack carries a clause reference. Classification rationales are stored next to the decision. Signatures capture re-auth, reason and Part 11 §11.50 manifestation. Nothing is magic — everything is auditable.

EU MDR 2017/745

EU IVDR 2017/746

FDA QMSR / 21 CFR 820

FDA 21 CFR 803 (MDR)

21 CFR Part 11

21 CFR Part 806

ISO 13485:2016

ISO 14971:2019

IEC 62304

IEC 62366-1

IEC 81001-5-1

EU NIS2

EU AI Act

EU Annex 11

GDPR

HIPAA (BAA)

MDSAP (AU/BR/CA/JP/US)

UKCA

PMDA

ANVISA

NMPA

TGA

Swissmedic / MedDO

GxP

Simple, transparent pricing.

Per-tenant subscription. Cancel any time. Stripe-hosted checkout — QMS Nordic never touches your card details.

Every plan includes the full QMS

All 30+ core modules unlocked from day 1. No module gates.

See all 30+ modules

Risk file (ISO 14971)

Clinical Evaluation Report (Article 61)

PMCF (Annex XIV Part B)

Vigilance + FSCA / Recall

Cybersecurity / SBOM (FDA + EU NIS2)

Submission Packager (FDA / EU / MDSAP)

CAPA workflow

Document control + Part 11 e-signatures

Real-time insights + KPIs

Or choose a paid plan

Founder

For pre-seed and seed-stage medtech. Get audit-ready before your first regulatory submission.

$254/month

Billed $3048/year · Save $540

All QMS modules
Up to 5 products
Up to 10 users
300k AI tokens / month
Audit-ready PDF export with MDR Annex IX metadata
Email support
Annual billing saves 15%

Choose Founder

Starter Growth

Enterprise

Multi-site, multi-region, validated SaaS deployment with NET-30 invoicing and a named CSM.

Custom

Everything in Starter Growth
Unlimited products + users
20M AI tokens / month
Dedicated tenant + isolated DB
Custom rule packs + onboarding
Validation pack (IQ/OQ/PQ)
NET-30 invoicing + multi-year contracts
99.9% SLA + named CSM

Talk to Sales

All-in pricing. No per-seat fees, no module add-ons, no AI surcharges. Every paid plan unlocks the full QMS feature surface — you only choose how many products and users you need.

Compare all features in detail

Feature	Free trial	Founder	Starter Growth	Enterprise
Core QMS
Products + classification (MDR + FDA wizard)
Documents + Part 11 e-signatures (WebAuthn)
Risk file (ISO 14971)
CAPA · Complaints · Audits · Suppliers · Training · Equipment · Validation
Software lifecycle (IEC 62304) — items + SOUP register + problem resolution
Usability engineering file (IEC 62366-1) with summative-evaluation gate
IVDR Performance Evaluation (Annex XIII three-pillar)
Management review with §5.6.2 inputs snapshot
Audit-ready PDF export with MDR Annex IX metadata
Post-market + clinical evidence
Clinical Evaluation Report (Article 61 + Annex XIV Part A) with AI auto-populate
Post-Market Clinical Follow-up plan (Annex XIV Part B) with AI auto-populate
PSUR (EU MDR Article 86) auto-aggregated
Vigilance reports (EU MDR Art. 87 / FDA §803)
FSCA / Recall (EU MDR Art. 87+89 / 21 CFR Part 806)
Customer satisfaction surveys + NPS + automation queue
Predicate device finder (510(k) + CER equivalence)
Cybersecurity
SBOM upload + AI vulnerability scan (NVD + GHSA + CISA KEV + MITRE)
Per-CVE review (Mitigated / Accepted / False Positive)
Activation gate on CRITICAL/HIGH open vulnerabilities
FDA premarket cybersecurity + EU NIS2 + IEC 81001-5-1 coverage
Operations add-ons (paid)
Stock module — lot-level inventory + QA quarantine + FSCA stock query	—	+$299/mo	+$599/mo
Procurement module — POs gated by ISO 13485 §7.4.1 supplier qualification + 3-way match	—	+$299/mo	+$599/mo
Stock + Procurement bundle	—	+$499/mo	+$799/mo
Submissions + market reach
Submission Packager (FDA 510k / EU MDR TD / IVDR PE / MDSAP / UKCA / PMDA / ANVISA / NMPA / TGA)
Per-market compliance dashboard with structural / supported / partial scoring
DPA + HIPAA BAA acceptance flow with audit-logged versions
AI
AI document drafting (Claude + RAG over your approved docs)	100k tokens / 30d	300k tokens/mo	2M tokens/mo	20M tokens/mo
AI Suggest hazards (Risk file)
AI Suggest root cause + CA / PA (CAPA)
AI Explain across the app
AI Helpdesk — auto-triage + Copilot drafts + Autopilot send	Copilot only	Copilot only
Customer experience
AI Helpdesk + KB · public ticket portal · email in/out
Real-time Insights dashboard (CAPA cycle, MTTR, AI autopilot ratio…)
Public read API + scoped Bearer tokens	—	—
Limits
Products	3	5	50	Unlimited
Users	5	10	100	Unlimited
Bulk CSV import	—	—
Daily overdue digest emails	—	—
Operations
Hash-chained audit trail
Cmd+K cross-module search
Reports + analytics dashboard
SSO (Google / Microsoft Entra / Okta)
Validation pack (IQ/OQ/PQ documentation)	—	—	—
Custom rule pack overlay	—	—	—
Dedicated tenant + isolated DB	—	—	—
Support
Email support
Slack support channel	—	—
Named CSM + onboarding	—	—	—
SLA	—	—	—	99.9%

All paid plans include the full QMS feature surface. Free tier is a 30-day evaluation with all features unlocked but lower limits. Stripe-hosted checkout — QMS Nordic never touches your card details.

Watch your Technical File assemble itself.

Pick a regime, pick a mode. The Annex II Pack composes from your live QMS data — numbered, cross-referenced, signature-ready. The same flow runs on every QMS Nordic tenant.

Live demo

Generate an Annex II Pack

Pick a regulatory regime + mode. QMS Nordic composes the canonical Technical Documentation File from a sample tenant in real time. Each row is a real document generator running on this machine.

DEMO-TDF-2026-001Sample tenant · Class I non-sterile

Regime

Mode

Awaiting selection

DEMO-DDD-001-v1.0.docxDevice Description Document
Annex II §1
18 KB
DEMO-UDI-001-v1.0.docxUDI / Basic UDI-DI Register
Annex II §1.1(a)
6 KB
DEMO-DVV-001-v1.0.docxDesign Verification & Validation
Annex II §6.1(b)
14 KB
DEMO-GSPR-001-v1.0.docxGSPR Compliance & Standards
Annex II §4 + MDCG 2021-8 Rev.2
22 KB
DEMO-RMF-001-v1.0.docxRisk Management File
Annex II §5 (ISO 14971)
28 KB
DEMO-MAT-001-v1.0.docxMaterials, Biocomp, Cleaning
Annex II §6
14 KB
DEMO-CER-001-v1.0.docxClinical Evaluation Report
Annex II §6.1(c) + Annex XIV A
19 KB
DEMO-PMS-001-v1.0.docxPMS Plan + Vigilance
Annex III + Article 84
11 KB
DEMO-PMSR-001-v1.0.docxAnnual PMS Report
Article 85
9 KB
DEMO-LBL-001-v1.0.docxLabelling Master + ISO 15223-1
Annex II §2
12 KB
DEMO-IFU-001-v1.0.docxInstructions for Use
Annex II §2
16 KB
DEMO-USE-001-v1.0.docxUsability Evaluation
Annex II §3 (IEC 62366-1)
10 KB
DEMO-QMS-001-v1.0.docxManufacturing & QMS
Annex II §1.1(d)
13 KB
DEMO-MRR-001-v1.0.docxManagement Review Record
ISO 13485 §5.6
8 KB
DEMO-PRRC-001-v1.0.docxPRRC + Conformity Assessment
Article 15 + 52(7)
7 KB
DEMO-DoC-001-v1.0.docxEU Declaration of Conformity
Article 19 + Annex IV
5 KB
DEMO-TDIDX-001-v1.0.docxMaster Index
Annex II §16
4 KB

This is a sample pack from a Class I non-sterile demo tenant. Generation runs end-to-end.

Try in sandbox Open in QMS Nordic

From classification to closure in three steps.

Register your device + markets

Tell QMS Nordic which markets you ship into — EU, US, UK, JP, MDSAP and more. The classification wizard fires the rules and cites the clauses live.

QMS Nordic generates the obligations

The versioned rule pack turns each classification into the exact tasks the standards demand, with per-market overlays for MDSAP, PMDA, ANVISA, TGA and NMPA layered in automatically.

Run the QMS, ship the evidence

Day-to-day work happens across 30+ integrated modules — CAPA, vigilance, audits, design controls, suppliers, production. Every action is hash-chain-audited and the Submission Packager bundles your evidence into a regulator-ready file in one click.

Reference customers

Running production QMS workloads on QMS Nordic.

Real Danish medical device manufacturers managing their EU MDR technical files, risk files, supplier qualifications, and audit trails inside QMS Nordic today.

JB-MEDICO ApS

Denmark

Active tenant

“QMS Nordic gave us a single audit-ready system for our entire Class I portfolio. The Submission Packager turned what used to be a binder full of cross-references into one click — our technical file is now always in the state an inspector wants to see it.”

Jesper Berg

CEO, JB-MEDICO ApS

Class I medical device manufacturer. Multi-product portfolio including IV poles, hygienic equipment rails, and patient-handling accessories. EU MDR self-certification.

Regulatory scope · EU MDR · ISO 13485 · ISO 14971

Easycrush ApS

Denmark

Active tenant

“We picked QMS Nordic because the audit trail is structurally immutable, not a configurable feature you can switch off. The hash-chained log and Part 11 e-signatures meant we passed our last MDR audit without a single observation on document control.”

Henk Hoppentocht

Founder, Easycrush ApS

Medical device manufacturer. Manages full QMS lifecycle in QMS Nordic — controlled documents, risk file, supplier qualification, and labelling artwork.

Regulatory scope · EU MDR · ISO 13485 · ISO 14971

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What you get with QMS Nordic.

Six capabilities that define how QMS Nordic is different — all included on every paid plan, from rules-as-data classification to AI helpdesk and the Submission Packager.

Submission Packager

Bundle evidence into FDA 510(k), EU MDR Technical File, IVDR PE, MDSAP, UKCA, PMDA, ANVISA, NMPA, TGA submissions. Required-section completeness scored in real time.

AI that knows it's a draft

CER, PMCF, predicate-finder, helpdesk Copilot, SBOM vuln scan — draft-only, human-approved, full provenance. Restricted to PubMed, MAUDE, EUDAMED, EMA, MHRA, NVD, CISA KEV — never random web pages.

Audit-grade trail

Append-only hash-chained events for every classification, edit, and signature. Postgres RLS forces tenant isolation at the DB.

Cybersecurity / SBOM included

Required by FDA's 2025 premarket cybersecurity guidance + EU NIS2. Upload CycloneDX or SPDX, AI scans NIST NVD + GitHub Security Advisories + CISA KEV. No competitor QMS ships this.

End-to-end MDR clinical evidence

CER (Article 61) + PMCF (Annex XIV Part B) + PSUR (Article 86) + FSCA (Article 87 / Part 806) — one connected workflow with shared traceability.

Insights without a data team

Real-time KPIs — CAPA cycle time, complaint MTTR, audit-finding age, training compliance %, helpdesk first-response, AI autopilot ratio. No warehouse, no cron.

Tenant-isolated by design

Postgres Row-Level Security forces every query through a per-tenant boundary. Cross-tenant data leakage is structurally impossible.

21 CFR Part 11 compliant

Hash-chained immutable audit log, e-signature manifestation per §11.50, re-auth on signing, WebAuthn-ready.

Inspector-ready exports

Every record exports as a paper-ready PDF with the MDR Annex IX manufacturer-of-record block, full audit trail, and signature lines.

FAQ

Is QMS Nordic a validated system?

QMS Nordic's workflow gates are structurally enforced (cannot close a CAPA without §820.100(a)(4) effectiveness verification, cannot close a management review without §5.6.3 outputs). The platform ships with a Validation pack covering IQ, OQ and PQ on Enterprise. The hash-chained audit log + per-tenant Postgres RLS satisfy 21 CFR Part 11 §11.10.

Which regulations do you cover?

EU MDR 2017/745, EU IVDR, FDA QMSR / 21 CFR Part 820, 21 CFR Part 11, Part 806, FDA premarket cybersecurity guidance, EU NIS2, ISO 13485:2016, ISO 14971:2019, IEC 62304, IEC 62366-1, IEC 81001-5-1, EU AI Act, GDPR, HIPAA (BAA on request). Each has a dedicated module that structurally enforces the standard's requirements.

Is the AI safe to use in a regulated context?

AI auto-populate retrieves only from your approved tenant documents (RAG via OpenAI embeddings) and a curated regulatory-registry allowlist (PubMed, MAUDE, EUDAMED, EMA, MHRA, NIST NVD, CISA KEV). Never random web pages. Output is labelled DRAFT, never auto-approved, requires human review + Part 11 §11.50 e-signature to promote. Full provenance retained on every record.

See all questions

See it on your data in 5 minutes.

Spin up a tenant, walk a CAPA from open to closure, export the audit-ready PDF. The whole thing runs in your browser — no install, no demo call required.

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