Terms of Use

DRAFT — pending legal review

1. General information only

The content, free tools and templates on this website provide general, preliminary information about medical device regulations and standards. They are not legal, regulatory or other professional advice and are not a regulatory determination for any specific device.

2. No consulting relationship

Using the website, tools or templates, or contacting us, does not create a consulting or any other professional relationship. Such a relationship exists only under a separate written agreement signed by both parties.

3. No warranty

The website, tools and templates are provided “as is” and “as available”, without warranties of any kind, express or implied, including accuracy, completeness, timeliness or fitness for a particular purpose. Regulations, guidance and standards change; results may not reflect the latest version.

4. Your responsibility

Regulatory decisions, classifications, risk acceptability criteria, technical documentation and submissions remain the sole responsibility of the manufacturer. Always verify results against the official texts and with your notified body, the FDA or the competent authority.

5. Limitation of liability

To the maximum extent permitted by applicable law, RegVia and its team are not liable for any direct, indirect, incidental, consequential or special damages, including loss of market access, delays, regulatory action, lost profits or data loss, arising from or related to the use of, or inability to use, the website, tools, templates or content.

6. No guarantees and services we do not provide

  • We do not guarantee FDA clearance or approval, CE certification or any other regulatory outcome.
  • We do not act as US Agent, EU Authorized Representative or Saudi Authorized Representative.
  • We do not provide legal services.
  • We are not affiliated with, or endorsed by, the FDA, the European Commission, notified bodies, SFDA, TİTCK or ISO.

7. Templates and downloads

You may use downloaded templates for your own internal purposes. Adapt and validate them before use. You may not resell or republish them as your own product.

8. Data entered into tools

Tool inputs are processed in your browser and are not sent to us. Only the details you submit in a form (for example, your name and email to download a file) are sent to us, as described in the Privacy Notice.

9. Third-party links

Links to official sources and other websites are provided for convenience. We are not responsible for their content or availability.

10. Intellectual property

The website design, text, tools and templates are owned by RegVia unless stated otherwise. Standards are referred to by number only; their content belongs to the respective standards bodies.

11. Governing law and changes

Governing law and jurisdiction: [ONAYLANACAK]. We may update these terms; the version published on this page applies. Last updated: [ONAYLANACAK].

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