Terms of Service

Last updated: 2026-06-18

These Terms of Service ("Terms") govern access to and use of the MDRpilot platform ("Service") operated by MDRpilot ("we", "us"). By creating an account or using the Service, you agree to these Terms on behalf of yourself and the organisation you represent ("Customer", "you").

1. Definitions

• Account — credentials and workspace assigned to an authorised user.
• Customer Data — information, files and documentation you upload or enter.
• Generated Output — drafts, analyses, translations and exports produced by the Service, including AI-assisted content.
• Subscription Plan — Starter, Basic, Plus, Pro or Enterprise tier with associated usage limits.

2. Scope of the Service

MDRpilot provides software tools to support preparation of medical device quality and regulatory documentation (including MDR technical files, ISO 13485 QMS artefacts, risk management drafts and related workflows). The Service is an assistance and productivity tool only. It does not:

• constitute legal, regulatory or clinical advice;
• replace notified body, competent authority or qualified person review;
• guarantee conformity, CE marking or market approval; or
• certify that any document is complete or submission-ready.

You remain solely responsible for verifying accuracy, applicability and approval of all outputs before internal use or regulatory submission.

3. Account registration and security

You must provide accurate registration information and maintain a valid contact email. You are responsible for safeguarding credentials and for all activity under your Account. Notify us promptly at support@mdrpilot.com of any suspected unauthorised access.

Access may be role-based (e.g. Owner, Consultant, Viewer). The Customer's designated Owner manages billing, invites and subscription changes.

4. Acceptable use

You agree not to:

• use the Service in violation of applicable law or regulatory obligations;
• attempt to bypass authentication, plan limits or security controls;
• upload malware, scrape the Service or interfere with its operation;
• use Generated Output as the sole basis for regulatory decisions without qualified human review;
• upload special categories of personal data (including patient health data) unless you have a lawful basis, appropriate agreements and have assessed associated risks.

We may suspend or terminate access for material breach, abuse or non-payment.

5. Subscription, billing and plans

5.1 Plans and limits

Usage limits (products, seats, AI tokens, exports) depend on your active Subscription Plan. Current limits are displayed in the application and on our pricing page.

5.2 Fees

Paid plans are billed in euros (EUR) unless otherwise agreed in writing. Basic is €250 per month; Plus is €450 per month when billed monthly.

5.3 Annual billing

When you choose annual billing for a paid plan, you pay for ten (10) months and receive twelve (12) months of service (two months free). The annual price equals ten times the then-current monthly list price unless a separate enterprise agreement applies. Annual fees are charged upfront and are non-refundable except where required by applicable law.

5.4 AI tokens

Live AI features consume monthly token allowances included in your plan. Additional token packs may be purchased separately. Unused monthly allowances do not roll over unless explicitly stated. Purchased extra tokens remain available until consumed.

5.5 Changes

We may modify plan features or list prices with reasonable notice. Price changes apply at the next renewal unless otherwise required by law.

6. Intellectual property

You retain all rights in Customer Data. You grant us a limited licence to host, process and transmit Customer Data solely to provide and improve the Service, enforce these Terms and comply with law.

We retain all rights in the Service, software, models, templates and documentation. Except for the limited right to use the Service during an active subscription, no ownership is transferred to you.

7. Confidentiality and data protection

Each party will protect the other's confidential information with reasonable care. Processing of personal data is described in our Privacy Policy, which forms part of these Terms.

8. AI features and third-party providers

When enabled, content you submit may be processed by configured third-party AI providers (e.g. OpenAI, Anthropic) to generate outputs you request. You are responsible for ensuring that such processing is permitted under your policies and applicable law. We do not guarantee availability, accuracy or fitness of AI outputs.

9. Warranties and disclaimer

THE SERVICE IS PROVIDED "AS IS" AND "AS AVAILABLE". TO THE MAXIMUM EXTENT PERMITTED BY LAW, WE DISCLAIM ALL WARRANTIES, EXPRESS OR IMPLIED, INCLUDING MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NON-INFRINGEMENT.

10. Limitation of liability

TO THE MAXIMUM EXTENT PERMITTED BY LAW, WE SHALL NOT BE LIABLE FOR INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL OR PUNITIVE DAMAGES, OR FOR LOSS OF PROFITS, DATA, REGULATORY APPROVAL OR BUSINESS OPPORTUNITY.

OUR AGGREGATE LIABILITY ARISING FROM THESE TERMS OR THE SERVICE SHALL NOT EXCEED THE FEES PAID BY YOU IN THE TWELVE (12) MONTHS PRECEDING THE CLAIM, OR €100 IF NO FEES WERE PAID.

Nothing in these Terms limits liability that cannot be limited under applicable law.

11. Term and termination

You may stop using the Service at any time. We may suspend or terminate access for breach, non-payment or discontinuation of the Service with notice where practicable.

Upon termination, your right to access the Service ends. Export your data before closure where the application provides export tools.

12. Governing law

These Terms are governed by the laws of the Republic of Türkiye, without regard to conflict-of-law rules, except where mandatory consumer protection rules of your country apply.

13. Contact

Questions regarding these Terms: support@mdrpilot.com