QMS Nordic

Terms of Service

Effective date: 2026-04-30 Last updated: 2026-04-30 Version: 1.0-draft (review by counsel before publication)

These Terms of Service ("Terms") govern your access to and use of the public Caelum website (caelum.app) and the Caelum QMS service (the "Service"). The Service is owned, developed, and copyright-protected by Aitech International ApS, a Danish private limited company ("Aitech", "Caelum", "we", "us"). The Caelum QMS™ name, logo, and software platform are intellectual property of Aitech International ApS and may not be used, copied, or reproduced without prior written permission.

By creating a Caelum account, signing in, or using the Service in any way, you accept these Terms on behalf of yourself and the organisation you represent ("Customer", "you"). If you do not accept these Terms, do not use the Service.

If your organisation has signed a Master Services Agreement with us, that agreement governs and these Terms are superseded for matters they cover.

1. The Service

Caelum is a Quality Management System (QMS) for life-science companies. We provide tools to assist your compliance with regulatory regimes including EU MDR, EU IVDR, FDA QMSR, ISO 13485, ISO 14971, IEC 62304, IEC 62366-1, 21 CFR Part 11, and EU Annex 11.

The Service is a tool, not legal or regulatory advice. Final responsibility for regulatory compliance, classification decisions, clinical claims, and submissions rests with you and your qualified regulatory professional.

2. Your account

2.1 Account creation

You must provide accurate information when creating an account and keep it up to date. You may only create an account on behalf of an organisation if you have authority to bind that organisation to these Terms.

2.2 Authorised users

You may invite individuals from your organisation as Authorised Users of your tenant. You are responsible for their acts and omissions and for ensuring they comply with these Terms.

2.3 Credentials

You are responsible for safeguarding your credentials. Notify us immediately at security@caelum.app if you suspect unauthorised access. We strongly recommend enabling SSO + MFA via your identity provider.

3. Acceptable use

You agree not to:

  • Reverse-engineer, decompile, disassemble, or attempt to derive

the source code of the Service

  • Use the Service to build a competing product
  • Submit content that infringes third-party rights or violates law
  • Submit malicious code, viruses, or harmful payloads
  • Attempt to access another tenant's data or escalate privileges
  • Probe, scan, or test the security of the Service except per a

coordinated disclosure agreement with us

  • Use the Service to send unsolicited communications, spam, or

unlawful marketing

  • Use the Service in violation of export-control or sanctions law
  • Misrepresent your identity or affiliation

We may suspend access immediately if we reasonably believe these restrictions have been breached, and will notify you as soon as possible.

4. Subscriptions, fees, and renewals

4.1 Plans

Plans, fees, included limits, and terms are described at caelum.app/#pricing or on the Order Form for Enterprise plans.

4.2 Free trial

The 30-day free trial is offered without payment. On day 31, unless you cancel, your tenant auto-converts to the Starter Growth plan. We will email you on day 25 with one-click cancellation.

4.3 Payment

Self-service plans are billed via Stripe Checkout (we never see your card number). Enterprise plans are invoiced. Fees are due as stated on the Order Form.

4.4 Late payment

Undisputed invoices unpaid 30 days after the due date may incur interest and may, after 14 days' notice, result in suspension.

4.5 Renewals

Subscriptions auto-renew at the end of each Subscription Term unless cancelled at least 30 days before the renewal date.

4.6 Refunds

Fees are non-refundable except as expressly stated. Mid-term downgrades take effect at the next renewal.

4.7 Taxes

Fees are exclusive of taxes; you are responsible for VAT, sales tax, and similar taxes other than taxes on Caelum's net income.

4.8 Price changes

We may change pricing on at least 30 days' written notice, taking effect at your next renewal.

5. Customer Data

5.1 Ownership

You retain all rights to the data you submit to the Service ("Customer Data"). You grant us a limited, worldwide, non-exclusive licence to host, process, copy, transmit, and display Customer Data solely to provide the Service.

5.2 Privacy

Our handling of personal data within Customer Data is governed by our Privacy Policy and, where applicable, our Data Processing Addendum. Where required by law, we will sign a HIPAA Business Associate Agreement.

5.3 Backups

We back up Customer Data per our Security Overview. You remain responsible for keeping copies of any Customer Data you cannot afford to lose.

5.4 Customer's responsibility

You warrant that you have all rights to upload Customer Data and that the upload does not violate any law or third-party right.

6. Caelum's intellectual property

The Service, including all software, designs, the rule pack, the Validation Pack, and the Documentation, is owned by Caelum and is protected by intellectual property laws. Except for the limited right to use the Service granted in these Terms, no other licence or right is granted, and we reserve all rights.

If you give us feedback, you grant us a perpetual, irrevocable, royalty-free licence to use it for any purpose without obligation.

7. AI features

Some features of the Service use third-party AI models (currently Anthropic Claude and OpenAI embeddings).

  • AI output is always labelled as a draft and never auto-promotes

to an effective record. You must review and apply an electronic signature to promote.

  • We capture provenance (model, prompt hash, retrieved chunks,

output hash) on every AI generation.

  • We have contractually disabled training-on-inputs with our AI

sub-processors. Your data is not used to train any model.

  • AI may produce inaccurate or incomplete output. You are

responsible for reviewing it before relying on it.

  • Helpdesk Autopilot mode sends only when AI confidence ≥ the

threshold you configure.

8. Third-party services

The Service may integrate with third-party services (identity providers, Stripe, Anthropic, etc.). Your use of those services is governed by their terms; we are not responsible for them. We choose sub-processors carefully and bind them per our DPA.

9. Disclaimers

EXCEPT AS EXPRESSLY SET OUT IN A SIGNED MASTER SERVICES AGREEMENT, THE SERVICE IS PROVIDED "AS IS" AND "AS AVAILABLE" WITHOUT WARRANTY OF ANY KIND. WE DISCLAIM ALL WARRANTIES, EXPRESS OR IMPLIED, INCLUDING IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, AND NON-INFRINGEMENT, TO THE MAXIMUM EXTENT PERMITTED BY LAW. WE DO NOT WARRANT THAT THE SERVICE WILL BE UNINTERRUPTED OR ERROR-FREE, NOR THAT IT IS A SUBSTITUTE FOR PROFESSIONAL REGULATORY AFFAIRS, LEGAL, OR CLINICAL JUDGMENT.

10. Limitation of liability

TO THE MAXIMUM EXTENT PERMITTED BY LAW:

  • Indirect / consequential / incidental / special damages.

Neither Party is liable for indirect, consequential, incidental, special, or punitive damages, or for lost profits, revenues, or data, even if advised of the possibility of such damages.

  • Cap. Each Party's aggregate liability arising out of these

Terms is limited to the amount you paid us under these Terms in the 12 months preceding the first event giving rise to liability.

  • Exclusions from cap. Caps do not apply to your payment

obligations, either Party's indemnification obligations, breach of confidentiality, or a Party's gross negligence, wilful misconduct, or fraud, or to any liability that cannot be limited under applicable law.

11. Indemnification

11.1 By you

You will defend, indemnify, and hold us harmless from any third-party claim arising out of (a) Customer Data; (b) your or your Authorised Users' breach of these Terms; or (c) your violation of applicable law.

11.2 By us

If a third party claims that the Service, as provided by us and used by you in compliance with these Terms, infringes its intellectual property rights, we will defend you and indemnify you for amounts finally awarded by a competent court or agreed in settlement.

11.3 Procedure

The indemnified party will give prompt notice, allow the indemnifying party sole control of the defence and settlement (provided no settlement may impose obligations on the indemnified party without consent), and provide reasonable cooperation.

12. Suspension and termination

12.1 By you

You may cancel at any time. If you cancel during a paid term, you remain liable for fees through the end of that term, but the service continues until the term ends.

12.2 By us

We may suspend or terminate access if you (a) materially breach these Terms and fail to cure within 30 days of notice; (b) fail to pay; or (c) become insolvent. We may suspend immediately for acceptable-use violations or security incidents.

12.3 Effect

On termination, we retain Customer Data for 90 days during which you may export. After 90 days, we delete it per our Privacy Policy and DPA.

13. Government use

If you are an instrumentality of a government, the Service is a "commercial item" within the meaning of FAR 2.101, and the restrictions on rights here apply notwithstanding any contrary provision.

14. Changes to the Service or these Terms

We may modify the Service from time to time. Material changes that adversely affect your use during a Subscription Term will be notified at least 30 days in advance.

We may update these Terms. If a change is material, we will notify you at least 30 days before it takes effect. Continued use after the effective date constitutes acceptance.

15. Force majeure

Neither party is liable for failure to perform (other than payment obligations) due to events beyond reasonable control.

16. Notices

We send notices to the email address on your account. You send notices to legal@caelum.app.

17. Governing law and forum

These Terms are governed by the laws of Denmark, excluding its conflict-of-laws principles and the United Nations Convention on Contracts for the International Sale of Goods. The courts of Copenhagen, Denmark have exclusive jurisdiction, except that either party may seek injunctive relief in any court of competent jurisdiction.

18. General

  • Entire agreement. These Terms (together with the Privacy

Policy, DPA, BAA where applicable, and any Order Form) form the entire agreement.

  • Assignment. You may not assign without our consent. We may

assign in connection with a corporate transaction.

  • No waiver. Failure to enforce a right is not a waiver.
  • Severability. If any provision is held unenforceable, the

rest remain in effect.

  • Independent contractors. The parties are independent

contractors; no agency, partnership, or employment is created.

  • Counterparts. Electronic acceptance has the same effect as a

signed original.

19. Contact

Aitech International ApS (owner and copyright holder of Caelum QMS) [REGISTERED ADDRESS] Denmark legal@caelum.app