Document control
Controlled documents with versioning and approvals.
Built for regulated medical device teams
Inspection-ready,
every single day.
A modern QMS built for medical device manufacturers.
Control documents, CAPAs, audits, training, risk, production traceability and technical documentation in one system — with AI assistance for regulated workflows.
See QMS Nordic using the workflows that matter to your organisation.
✓ EU-hosted✓ ISO 13485 workflows✓ EU MDR workflows✓ E-signatures & audit trails
Capabilities
The full quality system in one place.
Core QMS Nordic capabilities for medical-device quality teams.
CAPA management
Track corrective and preventive actions end to end.
Audit management
Plan, run and close internal and external audits.
Submission Packager
Bring your technical documentation together in one export, ready for an inspection or for you to submit.
Risk management
Identify, assess and control risk in ISO 14971 workflows.
E-signatures & audit trail
Electronic signatures with a traceable, hash-chained audit record.
Every capability is included in the QMS Nordic subscription.
View all features
Explore the complete QMS Nordic feature set by quality workflow.
Document control
- Controlled documents with versioning and approval workflows
- Document revision and change control
- Electronic approvals and signatures
- Training assigned automatically when a document revision takes effect
- Complete document history and traceability
CAPA & quality events
- Corrective and preventive action workflows
- Root-cause analysis and action tracking
- A CAPA closes only once its effectiveness is verified
- AI-suggested root causes, applied only by a person
Complaints, vigilance & FSCA
- Complaint intake and reportability assessment
- EU MDR Article 87 reporting deadlines, tracked from awareness
- Vigilance report drafting — you submit through EUDAMED or the competent authority
- Field safety corrective actions and recalls
Nonconformance & change control
- Nonconformance records and disposition
- Change control linked to the affected documents and risks
- Engineering change history on the audit trail
Production, incoming goods & dispatch
- Incoming goods received by lot and held in quarantine until inspected and released
- Incoming inspection with certificate of conformance; a rejection is linked to a nonconformance
- Production batches as device history records: work-instruction version, materials issued by received lot, in-process events and deviations
- Batch release after final inspection; a rejected batch is linked to a nonconformance
- Distribution records per shipment — consignee, lot and serial — for recall and field-action follow-up
- Traceability from received component lot through production batch to dispatch
- Device labels with GS1-128 barcodes
Audit management
- Plan and manage internal, supplier and external audits
- Record findings and follow-up actions
- Link findings to CAPAs
- Printable audit reports and exports
Suppliers
- Approved supplier list
- Supplier evaluation and re-qualification
- Supplier questionnaires
Submission Packager & technical documentation
- Organise technical documentation by product and product family
- Pin controlled records into the sections of a submission
- Completeness counted from released and approved evidence only
- An export for an inspection, or for you to submit to your notified body or authority
Risk management
- Hazards, hazardous situations and harms, with severity and probability
- Risk controls, their verification and residual risk
- Benefit-risk review
- Risk records per product or product family, with full history
Post-market surveillance
- PMS plans and PSURs
- Trend reporting
- PMCF plans and evaluations
E-signatures & audit trail
- Passkey-verified electronic signatures for document approval
- Signer, date and time, and the meaning of each signature, bound to the version signed
- Hash-chained, append-only audit trail
- Support for 21 CFR Part 11 workflows
Products & QMS planning
- Manage product families in one quality system
- QMS Calendar for planned quality activities
- Dashboard overview of quality-system work
- Unlimited products and users under the current subscription
- Interface in 23 European languages
QMS Nordic AI
- AI Inbox for reviewing AI-drafted work
- AI-assisted drafting of quality content
- Draft-and-approve workflow
- QMS Nordic AI chat and voice assistance
- AI-drafted documents take effect only after human approval
Consultant & auditor access
- One login across the client organisations you work for
- The role you hold in each organisation
- Time-limited access for external auditors, who can review and comment
Access, security & data
- Role-based access control
- Tenant isolation enforced in the database
- EU hosting and storage (Frankfurt)
- Sub-processors and transfer safeguards disclosed publicly
- Data Processing Agreement and security documentation
Software validation support
- Our validation evidence: master plan, requirements, traceability and test evidence
- Templates for your validation SOP, risk assessment, test protocol and report
- Your organisation validates the system for its own intended use
Built for teams that get audited
JB-MEDICOEASYCRUSHVOSS INDUSTRY
Our launch partners
Why QMS Nordic
Your QMS shouldn’t create more work.
Replace scattered files and manual follow-up with controlled workflows designed around the way regulated quality teams actually work.
Without QMS Nordic
× Scattered Word files and folders
× Excel trackers and manual reminders
× CAPAs followed through email
× Separate training records
× Last-minute audit preparation
With QMS Nordic
✓ Controlled documents and revision history
✓ Connected quality workflows
✓ CAPA traceability and approvals
✓ Training evidence in one place
✓ Records you can retrieve when the auditor asks
The platform
One system. Your entire quality operation.
Move from finding to approved record without losing the context, ownership or audit trail along the way.
Operational overview
Know what needs attention now.
See vigilance reporting deadlines, recurring quality obligations and the current state of your QMS in one view. Reports are prepared in QMS Nordic and submitted by you through EUDAMED or the competent authority.
✓ Vigilance deadline tracking✓ Ongoing obligations✓ Compliance deadlines
AI assistance
AI assistance without giving up quality control.
Use AI to help draft, summarise and surface information. Your quality team remains responsible for review and approval.
1. AI assistsDraft and organise quality information.
2. Human reviewsQA/RA verifies the output and context.
3. Authorised approvalThe right person approves the controlled record.
4. Audit trail recordsThe history remains connected and traceable.
Regulated workflows
Built for medical device quality systems.
QMS Nordic provides controlled workflows and evidence structures that support regulated quality operations. Your organisation remains responsible for its own compliance and intended-use validation.
13
ISO 13485
Document control, records, CAPA, training and quality workflows.
MDR
EU MDR
Quality and technical-documentation workflows for medical device manufacturers.
R
ISO 14971
Structured risk-management records and traceability.
11
21 CFR Part 11
Electronic-signature and audit-trail functionality for regulated records.
Software validation
Validation shouldn't start with a blank Word document.
QMS Nordic publishes its own validation evidence and gives you templates for yours. Your organisation remains responsible for validating the system for its own intended use.
Validation Master Plan
Requirements & traceability matrix
Test evidence report
Validation SOP template
Risk assessment template
Validation report template
Built for regulated quality teams
Everything you need to evaluate QMS Nordic.
Understand the platform, regulatory fit, implementation, AI controls, security, validation support and commercial model before you book a walkthrough.
One controlled quality system
Bring document control, CAPA, audits, risk management, production and dispatch records, electronic approvals and technical-file workflows together instead of managing quality across disconnected files and trackers.
Designed around medical-device workflows
Built to support workflows associated with EU MDR, ISO 13485, ISO 14971, FDA QMSR and 21 CFR Part 11. QMS Nordic supports your quality system; your organisation remains responsible for regulatory compliance.
AI with human oversight
Use AI to assist drafting, summarisation and quality work. AI-drafted documents remain drafts for human review and approval rather than automatically becoming effective controlled records.
Records ready for inspection
Controlled versions, approvals, electronic signatures and traceable audit records make it easier to retrieve the evidence your quality team and auditors need.
EU-hosted data protection
Customer data is stored and hosted in the EU (Frankfurt), with role-based access controls, encryption and tenant isolation. AI features send the relevant content to AI providers in the United States under Standard Contractual Clauses; every sub-processor is listed publicly.
Validation support
Our validation evidence and templates support your intended-use software validation. Your organisation performs and approves the validation required for its own intended use.
From your current QMS to QMS Nordic
A practical path to implementation.
We use the demo to understand your existing document structure, quality processes and migration scope. In the product, a step-by-step setup checklist then helps your team establish the core controlled workflows and bring existing records in.
01Workflow demoSee the actual platform using the processes relevant to your QA/RA team.
02Migration scopeReview the documents, records and data that need to move.
03Configuration & in-system guidanceSet up users, roles and controlled quality workflows.
04Validate & go liveComplete your intended-use validation and release the system under your QMS.
Pricing
One platform. One complete feature set.
Evaluate QMS Nordic through a guided 30-minute demonstration of the actual platform before subscribing.
Complete feature set · Unlimited users · Unlimited product families · 5M AI tokens per 12-month period · One hour of regulatory consulting a year · Support included
Extra AI tokens: €60 per million. Evaluation is by guided demonstration.
Data protection & security
Designed for controlled quality records.
Customer data is stored and hosted in the EU. QMS Nordic uses role-based access controls, electronic signatures and traceable audit records. AI features send the relevant content to providers in the United States, listed on our sub-processor page. Full contractual details are in the Data Processing Agreement.
Questions about QMS Nordic
What your QA, RA, IT and management teams will want to know.
Can QMS Nordic make us compliant?
No software can certify or guarantee compliance. QMS Nordic gives you controlled workflows, records, e-signatures and a hash-chained audit trail built around ISO 13485, EU MDR and ISO 14971. Compliance remains your organisation's responsibility.
How do we evaluate QMS Nordic?
In a 30-minute walkthrough of the real platform, built around your workflows and your QA/RA questions. There is no free trial.
How long does implementation take?
It depends on the records you bring and how your processes are set up; we estimate it with you in the demo. In the product, a step-by-step setup checklist takes your team through users, roles, core SOPs and training.
Can we migrate our existing records?
Yes. Products, suppliers and equipment import from CSV templates, and controlled documents are brought in one at a time and version-controlled from then on. We'll scope your migration with you in the demo.
Who validates the software?
You validate it for your intended use. Our validation pack is public: the Validation Master Plan, requirements, traceability matrix and test evidence, plus templates for your validation SOP, risk assessment, test protocol and validation report.
Where is our data, and who processes it?
The database and the application run in Frankfurt. AI features send the relevant content to Anthropic (drafting and chat) and OpenAI (search and voice) in the United States under the EU Standard Contractual Clauses, and spoken replies are generated by ElevenLabs. Customer data is not used to train AI models. The full list is on our sub-processor page.
How does AI fit into a regulated QMS?
AI drafts and suggests; people decide. AI-drafted documents are marked as such, take effect only after an authorised person approves them, and the audit trail records their AI origin. The helpdesk AI drafts replies but never sends one.
Can we export our data if we leave?
Yes. An administrator can export the whole organisation as one archive: every record as JSON and CSV, the audit log and the document index.
We're a consultancy or PRRC working for several manufacturers. Does that work?
Yes. One login can belong to several client organisations, with the role you hold in each, and external auditors get time-limited access of their own.
Which languages are available?
The interface is available in 23 European languages. Choose yours in the top bar.
Resources
Evaluate on your own time.
Everything below is public — no demo or sign-up needed.
Free EU MDR classification tool →
See your device's likely MDR class in a few minutes.
Validation pack →
Our validation evidence, and templates for yours.
Security overview →
How we protect your data, for your InfoSec review.
Sub-processors →
Every company that processes customer data for us, and where.
Data Processing Agreement →
The terms under which we process your data.
System status →
Live status of the platform.
See what an inspection-ready QMS looks like.
Book a 30-minute walkthrough.
We'll focus on your quality workflows, regulatory requirements and current QMS challenges.
See the actual platform. Bring your QA/RA questions.