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    Terms of Service

    Last Updated: July 2026

    These Terms of Service govern access to and use of the Xyreg workspace, provided by Xyreg SARL, a company incorporated under the laws of Luxembourg, having its registered address at House of BioHealth, 27 Rue Henri Koch, L-4354 Esch-sur-Alzette, Luxembourg. By creating an account, starting a trial or using the service, you accept these Terms.

    1. Acceptance of Terms

    By creating an account, starting a free trial or otherwise using Xyreg, you agree to be bound by these Terms and by our Privacy Policy. If you accept on behalf of a company, you confirm that you are authorised to bind that company.

    2. Description of Services

    Xyreg provides a cloud workspace for medical device teams covering electronic quality management (eQMS), product lifecycle management, design and development records, risk and usability files, regulatory dossier preparation and project management, together with the Xyreg Cortex AI assistant. We may improve, modify or discontinue individual features with reasonable prior notice.

    3. Subscriptions, Trials and Billing

    • Genesis: EUR 290 per month on an annual plan, or EUR 349 per month billed monthly. Limited to 2 named users. Optional modules are available at EUR 50 per module per month. • Helix Workspace: EUR 990 per month on an annual plan, or EUR 1,190 per month billed monthly. • PRRC as a Service: from EUR 2,990 per month for Class I devices, scoped per engagement. • Free trial: 7 days. You may cancel at any time during the trial at no cost; no charge is made unless you continue after the trial ends. • Prices are exclusive of VAT. Annual plans are invoiced in advance; monthly plans renew automatically until cancelled with 30 days' notice before the end of the current term. • Eligibility conditions for Genesis (pre-revenue teams, maximum 2 users) apply throughout the subscription.

    4. No Regulatory or Legal Advice

    Xyreg is a software tool. It does not provide legal, regulatory or clinical advice and does not act as your Notified Body, Authorised Representative or consultant, except where a separate written services agreement (for example PRRC as a Service) expressly states otherwise. You remain the legal manufacturer and remain solely responsible for the content, accuracy, review and approval of your technical documentation and for compliance with ISO 13485, Regulation (EU) 2017/745, FDA requirements and any other applicable rules. Output generated by Xyreg Cortex AI is a draft that must be reviewed and approved by qualified personnel before use.

    5. User Accounts

    You are responsible for: • Keeping account credentials confidential • All activity carried out under your accounts • Providing accurate and current information • Notifying us without delay of any unauthorised access Named user seats are personal and must not be shared.

    6. Acceptable Use

    You agree not to: • Breach applicable laws or regulations • Infringe intellectual property rights • Attempt to access systems or data without authorisation • Upload malicious code or unlawful content • Reverse engineer the workspace or interfere with its operation • Resell or provide the service to third parties without our written agreement

    7. Intellectual Property and Your Data

    Xyreg and all workspace software, templates and content remain our intellectual property. You retain full ownership of the data and documents you upload. You grant us a limited licence to host and process that data solely to deliver the service. On termination you may export your data in machine-readable form.

    8. Availability and Support

    We aim for high availability and perform maintenance with advance notice where practicable. Support is provided by email and through the workspace during Luxembourg business hours. Specific service levels apply only where agreed in a written order form.

    9. Limitation of Liability

    To the maximum extent permitted by law, Xyreg is not liable for indirect, incidental or consequential damages, loss of profit, loss of data beyond our backup obligations, or regulatory sanctions arising from your use of the workspace. Our aggregate liability is limited to the fees paid by you in the 12 months preceding the event giving rise to the claim. Nothing limits liability for fraud, wilful misconduct or death and personal injury.

    10. Termination

    Either party may terminate at the end of the current subscription term with 30 days' written notice. We may suspend or terminate access immediately for material breach or non-payment. After termination you have 30 days to export your data, after which it is deleted in line with our Privacy Policy.

    11. Governing Law and Jurisdiction

    These Terms and any dispute or claim arising out of or in connection with them or their subject matter (including non-contractual disputes or claims) shall be governed by and construed in accordance with the laws of the Grand Duchy of Luxembourg, without giving effect to any principles of conflicts of law. The parties irrevocably submit to the exclusive jurisdiction of the courts of Luxembourg City.

    12. Changes to Terms

    We may update these Terms. Material changes are notified at least 30 days in advance; continued use after they take effect constitutes acceptance.

    Questions about these terms? Send us a message and we will reply by email.