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Terms of Use

Effective date: 21 May 2026

These terms govern your use of the website at evalda.io. By accessing or using the site, you agree to these terms. If you do not agree, do not use the site. These terms apply to the marketing website only; if you become a customer of the Evalda product, a separate Customer Agreement will govern your use of the product.

1. Who we are

The website is operated by ITNas Ltd., a Bulgarian limited company (EIK 208793733), with registered address at 6 Mihail Sarafov Street, Sukhata Reka, Poduyane District, 1505 Sofia, Bulgaria. References to "Evalda," "we," "us," and "our" in these terms mean ITNas Ltd..

2. The site and its content

The website provides information about Evalda, an AI-native regulatory intelligence platform for European medical device regulatory affairs work, currently in v1 development. The site is for informational purposes and to facilitate inquiries about the product.

3. Regulatory information disclaimer

Read this section carefully.

Evalda and the content on this website are provided for informational purposes only. Nothing on the site constitutes:

  • regulatory advice or legal counsel under EU MDR (Regulation 2017/745), EU IVDR (Regulation 2017/746), the EU AI Act (Regulation 2024/1689), the US Federal Food, Drug, and Cosmetic Act, or any other regulatory framework;
  • a substitute for consultation with a qualified regulatory affairs professional;
  • a pre-submission (Q-Sub) meeting with the US Food and Drug Administration, a Notified Body opinion, or a formal regulatory assessment;
  • a guarantee of regulatory outcome.

A classification result, standards mapping, literature search output, or any other Evalda output indicates a probable regulatory pathway only. Market authorization requires a full dossier, a complete technical file, or a 510(k) submission demonstrating substantial equivalence or conformity. Guidance documents, product codes, and predicate devices are indexed at the date of ingestion into our corpus; subsequent amendments or new guidance may post-date the snapshot used in any analysis.

You are responsible for verifying any regulatory output against current source documents and for engaging qualified regulatory professionals for binding regulatory decisions affecting your devices.

4. Acceptable use

You agree not to:

  • use the site in any way that violates applicable law or regulation;
  • attempt to gain unauthorized access to any part of the site or its underlying systems;
  • introduce viruses, malware, or other harmful code to the site;
  • scrape, harvest, or mass-extract content from the site without our written consent;
  • impersonate any person or entity in your communications with us;
  • use the site to send unsolicited commercial communications.

5. Intellectual property

The site, including its design, code, copy, illustrations, product mockups, and the Evalda name and logo, is the intellectual property of ITNas Ltd., except where third-party content is clearly attributed. You may not copy, modify, distribute, or create derivative works from the site or its content without our prior written consent. You may share links to individual public pages of the site.

Trademarks, logos, and brand names of third parties referenced on the site (notified bodies, regulatory agencies, standards organizations, and others) remain the property of their respective owners.

6. Third-party links and content

The site may contain links to third-party websites, regulatory documents, or other external content. We do not control and are not responsible for the content, accuracy, or availability of any external resources. Links are provided for convenience only and do not imply endorsement.

7. Limitation of liability

To the maximum extent permitted by applicable law:

  • The site and all content are provided "as is" and "as available," without warranties of any kind, express or implied, including warranties of merchantability, fitness for a particular purpose, accuracy, completeness, or non-infringement.
  • We are not liable for any indirect, incidental, special, consequential, or punitive damages arising out of or related to your use of the site, including loss of profits, loss of data, regulatory delays or rejections, or business interruption, regardless of the legal theory of liability and regardless of whether we have been advised of the possibility of such damages.
  • Our aggregate liability arising out of or related to the site is limited to one hundred euros (EUR 100). Because access to the site is free of charge, this represents the practical cap on any claim.

Nothing in these terms excludes or limits liability that cannot lawfully be excluded or limited under Bulgarian law, including liability for death, personal injury caused by negligence, or fraud.

8. Changes to the site and these terms

We may modify, suspend, or discontinue any part of the site at any time without notice. We may revise these terms from time to time. The effective date at the top reflects the most recent revision. Continued use of the site after a revision constitutes acceptance of the revised terms.

9. Governing law and jurisdiction

These terms are governed by the laws of the Republic of Bulgaria, without regard to conflict-of-laws principles. Any dispute arising out of or related to these terms or your use of the site will be resolved in the competent courts of Sofia, Bulgaria, unless mandatory consumer protection law of your country of residence provides otherwise.

10. Contact

For questions about these terms:

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