Inspection-ready, every single day.
QMS Nordic is the quality management system built for medical device manufacturers — document control, CAPA, audits and training in one place, with an AI assistant that does the heavy lifting.
No card required · Full access · Cancel free anytime before the trial ends.
Built for teams that get audited
Danish medical device manufacturers run their entire MDR quality system on QMS Nordic.
““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.””
Class I medical device manufacturer. Multi-product portfolio including IV poles, hygienic equipment rails, and patient-handling accessories. EU MDR self-certification.
““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.””
Medical device manufacturer. Manages full QMS lifecycle in QMS Nordic — controlled documents, risk file, supplier qualification, and labelling artwork.
““As an ISO 13485 component supplier, our customers' auditors want to see traceability and document control that actually holds up. QMS Nordic gave production and QC one controlled system — every drawing revision, inspection record and change request linked and version-controlled. When a customer audits us, we pull the full history of a part in seconds instead of digging through binders.””
ISO 9001 and ISO 13485 certified precision manufacturer of components for medical device OEMs. Runs document control, change control and incoming & in-process inspection in QMS Nordic.
Why QMS Nordic
Everything a regulated quality team needs — without the enterprise price tag or the six-month rollout.
Always inspection-ready
Controlled documents, complete audit trails and e-signatures keep you ready for an auditor walking in tomorrow.
AI that does the legwork
Draft CAPAs, summarise findings and surface risks in seconds — your team reviews and approves.
Live in days, not months
Guided onboarding and structured import get core document control running fast.
All features, every plan
No feature gating. Plans differ only by products, users, support level and AI credits.
Predictable pricing
Clear monthly pricing, longer terms save more, and AI top-ups at cost — no surprise bills.
EU-hosted & GDPR-ready
Your data stays in the EU, encrypted in transit and at rest.
Capabilities
The full quality system in one place. Tap any capability to see what's included.
Every capability is included in all plans.
Simple, all-inclusive pricing
One subscription. Every feature, unlimited products and users, nothing gated. Prices excl. VAT.
excl. VAT · on a two-year subscription
Saves €1,800 a year
- Every feature — document control through to the Submission Packager
- Unlimited products and users
- 5,000,000 AI tokens a year
- One hour of regulatory consulting a year
- 30 days free to start — no card
30 days free to start — no card required.
- One document drafted from scratch — about 12,000 tokens
- A full technical file for one product family, 17 documents — about 200,000 tokens
- The 5,000,000 included — roughly 25 product families
- Speaking with the assistant uses about 11× the tokens of typing — roughly 4 hours of conversation
- Beyond that, €60 per million: an extra product family costs about €12
Estimates from real drafting runs, not caps. If you run out, only the AI pauses — you top up at €60 per million rather than getting a surprise bill.
Included every year: 5,000,000 AI tokens and one hour of regulatory consulting. Beyond that, tokens are €60 per million and consulting €240 an hour.
AI tokens, in plain language
Your subscription includes 5,000,000 AI tokens a year. Need more? Top up at €60 per million, whenever you want.
What uses a token?
Each AI action uses tokens in proportion to the size of the request and the draft it returns. A detailed usage guide is available in-app.
Top up at any time
€60 per million tokens. Buy only what you need — a further product family is about €12.
Run out? Nothing breaks
Only the AI assistant pauses until you top up. Every other feature keeps working. No surprise overage bills.
Prefer to see it first?
Book a 30-minute walkthrough. We'll show your exact workflows and answer the compliance questions your auditor will ask.
Book a demo- See document control & e-signatures live
- Walk through a mock audit export
- Get a migration estimate for your records
- No slides — your data model, your questions
Start free
Thirty days, full access, no card. Your term begins only when the trial ends.
on a two-year subscription · excl. VAT
Request a demoNo card required now. VAT and company number are collected later, at workspace setup. EU-hosted.
Questions buyers actually ask
How long does implementation take?
Most teams run core document control within days. Guided onboarding is included with every subscription.
Can we migrate our existing records?
Yes — structured import of documents, training records and CAPAs. We'll give you a migration estimate during your demo or trial.
Is it suitable for regulated medical device use?
Built for EU MDR, ISO 13485, ISO 14971 and 21 CFR Part 11 workflows — controlled documents, hash-chained audit trail, e-signatures. You remain responsible for validating the system for your intended use.
Can we export our data if we leave?
Yes — your data is yours, exportable on request. See our Data Processing Agreement for export and deletion terms.
Do I need a credit card to start?
No. The 30-day trial requires no card. Billing details are collected only at workspace setup if you continue.
What happens when the trial ends?
Your plan converts to the term you chose (minimum 12 months), billed monthly excl. VAT. Cancel free any time before the trial ends. See the Subscription Agreement for full terms.
Are all features in every plan?
Yes. Plans differ only by product families, users, support level and monthly AI credits.
What uptime and support can we expect?
Availability targets and support response times are set out in our Service Level Agreement. Every subscription gets the same support — there is no higher tier to buy.
Which languages are available?
The interface is available across Scandinavian and EU languages — use the language selector in the top bar.
Inspection-ready, every single day.
Start your 30 days free — no card, full access.