Interpretation and Definitions

Interpretation

The words whose initial letters are capitalized have meanings defined under the following conditions. The following definitions shall have the same meaning regardless of whether they appear in singular or in plural.

Definitions

For the purposes of this Disclaimer:

  • Company (referred to as either “the Company”, “We”, “Us” or “Our” in this Disclaimer) refers to REGNOVIX.
  • Service refers to the Website.
  • You means the individual accessing the Service, or the company, or other legal entity on behalf of which such individual is accessing or using the Service, as applicable.
  • Website refers to REGNOVIX, accessible from https://regnovix.com/.

Disclaimer

The information contained on the Service is for general information purposes only.

The Company assumes no responsibility for errors or omissions in the contents of the Service.

In no event shall the Company be liable for any special, direct, indirect, consequential, or incidental damages or any damages whatsoever, whether in an action of contract, negligence or other tort, arising out of or in connection with the use of the Service or the contents of the Service.

The Company assumes no responsibility for errors or omissions in the contents of the Service. In no event shall the Company be liable for any special, direct, indirect, consequential, or incidental damages or any damages whatsoever, whether in an action of contract, negligence or other tort, arising out of or in connection with the use of the Service or the contents of the Service. The Company reserves the right to make additions, deletions, or modifications to the contents on the Service at any time without prior notice.

The Company does not warrant that the Service is free of viruses or other harmful components.

External Links Disclaimer

The Service may contain links to external websites that are not provided or maintained by or in any way affiliated with the Company.

Please note that the Company does not guarantee the accuracy, relevance, timeliness, or completeness of any information on these external websites.

Errors and Omissions Disclaimer

The information given by the Service is for general guidance on matters of interest only. Even if the Company takes every precaution to ensure that the content of the Service is both current and accurate, errors can occur. Plus, given the changing nature of laws, rules and regulations, there may be delays, omissions or inaccuracies in the information contained on the Service.

The Company is not responsible for any errors or omissions, or for the results obtained from the use of this information.

Fair Use Disclaimer

The Company may use copyrighted material which has not always been specifically authorized by the copyright owner. The Company is making such material available for criticism, comment, news reporting, teaching, scholarship, or research.

The Company believes this constitutes a “fair use” of any such copyrighted material as provided for in section 107 of the United States Copyright law (or equivalent provisions under applicable law).

If You wish to use copyrighted material from the Service for your own purposes that go beyond fair use, You must obtain permission from the copyright owner.

Views Expressed Disclaimer

The Service may contain views and opinions which are those of the authors and do not necessarily reflect the official policy or position of any other author, agency, organization, employer or company, including the Company.

If the Service allows users to post content (including comments), such content is the sole responsibility of the user who posted it. The Company is not liable for user-generated content and reserves the right to remove it for any reason.

No Responsibility Disclaimer

The information on the Service is provided with the understanding that the Company is not herein engaged in rendering legal, accounting, tax, or other professional advice and services. As such, it should not be used as a substitute for consultation with professional accounting, tax, legal or other competent advisers.

In no event shall the Company or its suppliers be liable for any special, incidental, indirect, or consequential damages whatsoever arising out of or in connection with your access or use or inability to access or use the Service.

“Use at Your Own Risk” Disclaimer

All information in the Service is provided “as is”, with no guarantee of completeness, accuracy, timeliness or of the results obtained from the use of this information, and without warranty of any kind, express or implied, including, but not limited to warranties of performance, merchantability and fitness for a particular purpose.

The Company will not be liable to You or anyone else for any decision made or action taken in reliance on the information given by the Service or for any consequential, special or similar damages, even if advised of the possibility of such damages.

MIRforge tool

MIRforge (mirforge.regnovix.com) is an AI-assisted regulatory tool designed to support the preparation of Manufacturer Incident Reports (MIR) and Field Safety Corrective Action (FSCA) documents for submission to regulatory authorities.

While every effort is made to ensure the structured XML output aligns with current MHRA and EU MDR schema requirements, Regnovix does not warrant that outputs are free from errors, omissions, or that they will be accepted by any regulatory authority. The accuracy of generated outputs depends on the quality and completeness of the source documents uploaded by the user.

Users must independently review, validate, and verify all generated XML content for accuracy, completeness, and regulatory compliance before submission to MHRA, EU MDR competent authorities, FDA, or any other regulatory body.

Use of MIRforge does not constitute regulatory, legal, or medical advice. For regulatory guidance specific to your organisation and device, please consult a qualified regulatory affairs professional.

Regnovix accepts no liability for any regulatory, legal, or commercial consequences arising from submissions made using MIRforge output.

Contact Us

If you have any questions about this Disclaimer, You can contact Us:

Last updated: March 15, 2026