Terms and Conditions
TERMS AND CONDITIONS
Last updated: January 15, 2026
1. Introduction and Acceptance
These Terms and Conditions ("Terms") govern the use of the Leida service ("Service") provided by LEIDA TECH ("we", "us").
By accessing or using the Service, you agree to be bound by these Terms.
If you do not agree, you may not use the Service.
2. Description of the Service
The Service is a cloud-based SaaS platform providing AI-powered regulatory roadmaps, automated compliance documentation and real-time regulatory intelligence, with a particular focus on pharmaceutical and healthcare sector regulation, including MDR, IVDR, ISO standards and global regulatory frameworks.
The Service:
The Service is designed exclusively for business-to-business (B2B) use by professional users and is not intended for consumers. The Service:
generates automated MDR/IVDR documentation, technical files and declarations;
provides dynamic regulatory roadmaps for MD and IVD classifications, updated in real time as regulations evolve;
centralises risks, requirements and supporting evidence for audit-readiness;
accelerates CE marking and notified body submissions with AI-assisted templates and validation tools;
delivers continuous monitoring and instant alerts on regulatory changes, standards updates and guidance documents;
provides a regulatory intelligence hub with structured, searchable knowledge across MDR, IVDR, ISO standards and global frameworks;
does not provide legally binding advice;
does not replace professional legal, regulatory or compliance assessment.
Any outputs generated by the Service are for informational and decision-support purposes only.
3. Registration and Accounts
Use of the Service requires registration.
You agree to:
provide accurate and up-to-date information;
keep access credentials confidential;
promptly notify us of unauthorised access.
You are responsible for all activity under your account.
4. Right of Use
We grant you a limited, non-exclusive, non-transferable right to use the Service during your subscription period, solely for your internal business purposes.
You may not:
copy, modify or reverse engineer the Service;
provide access to third parties without authorisation;
use the Service for unlawful or misleading purposes;
interfere with the security or integrity of the Service.
5. Subscription, Fees and Payment
The Service is provided on a subscription basis.
Fees are charged in advance according to the selected plan.
Prices may be updated with reasonable advance notice.
Failure to pay may result in suspension or termination.
All fees are exclusive of applicable taxes.
6. Customer Data
6.1 Ownership
You retain all rights to data and content you upload or create in the Service ("Customer Data").
We do not claim ownership of Customer Data.
6.2 Use of Customer Data
We may process Customer Data solely to provide and maintain the Service, including security, support and service improvements.
6.3 Customer Responsibility
You are responsible for:
the legality and accuracy of Customer Data;
ensuring you have the right to use and upload such data;
backing up your data where appropriate.
7. Data Export and Deletion
You may export your Customer Data using the available Service functionalities or upon reasonable request.
Upon termination, you may request export of Customer Data within a reasonable period. After this period, we may delete Customer Data unless retention is required by law.
Upon request, we shall provide reasonable assistance to enable you to fulfil your obligations under applicable data protection laws, including Regulation (EU) 2016/679 (GDPR). The processing of personal data is governed by our Data Processing Agreement and Privacy Policy, which form an integral part of these Terms.
8. Use of AI and Regulatory Classification
The Service is a B2B artificial intelligence system within the meaning of Regulation (EU) 2024/1689 (AI Act). The Service includes automated and AI-based features that:
analyse inputs;
generate suggestions or structured outputs;
support regulatory understanding and decision-making.
You acknowledge that:
outputs are not legally binding;
outputs may contain inaccuracies;
final decisions and compliance actions remain your responsibility.
The Service has been classified as a non-high-risk AI system under the AI Act. The Service is not a safety component of a product covered by Union harmonisation legislation listed in Annex I of the AI Act, nor does it fall within the high-risk use cases listed in Annex III of the AI Act. We do not guarantee the accuracy, completeness or timeliness of regulatory information provided by the Service.
In accordance with Article 50 of the AI Act, we inform you that you are interacting with an AI system when using the Service. Content generated by the Service is marked as AI-generated where technically feasible. The Service is a professional B2B compliance tool and does not constitute a consumer-facing chatbot or generative content creation service.
The Service utilises third-party artificial intelligence models and components. Information regarding the AI models and sub-processors used in the provision of the Service is available upon request.
9. Availability and Maintenance
We aim to provide the Service with reasonable availability but do not guarantee uninterrupted operation.
We may perform maintenance or updates that temporarily affect availability.
The Service is provided "as is" and "as available".
10. Intellectual Property
All intellectual property rights in the Service, including software, content and trademarks, belong to us or our licensors.
Non-confidential feedback provided by you may be used freely to improve the Service.
11. Limitation of Liability
To the extent permitted by law, we are not liable for:
indirect or consequential damages;
loss of profits, business or data;
reliance on outputs generated by the Service.
Our total liability is limited to the fees paid by you during the twelve (12) months preceding the event giving rise to the claim.
This limitation does not apply to liability that cannot be excluded under mandatory law, including liability arising from gross negligence, willful misconduct or breach of data protection obligations.
12. Term and Termination
The agreement is valid for the subscription period and renews automatically unless terminated.
Either party may terminate:
at the end of the subscription period; or
immediately in case of material breach, provided that the breaching party has been given written notice and a period of thirty (30) days to cure such breach, unless the breach is incapable of cure.
Upon termination, your right to use the Service ends.
13. Changes to the Terms
We may update these Terms from time to time.
Continued use of the Service constitutes acceptance of the updated Terms.
14. Force Majeure
Neither party is liable for failure to perform due to events beyond reasonable control.
15. Governing Law and Disputes
These Terms are governed by the laws of FINLAND, excluding conflict-of-law rules.
Disputes shall be resolved primarily through negotiation and, failing that, by the competent courts of FINLAND.
16. NIS2 Compliance
The applicability of Directive (EU) 2022/2555 (NIS2) to the Service is subject to ongoing assessment. We implement appropriate technical and organisational measures to ensure the security of the Service. In the event of a significant security incident affecting the Service, we shall notify affected customers without undue delay.
17. Contact Information
LEIDA TECH OY
3538835-9