Terms of Service
1. Acceptance of Terms
By accessing or using this website (meddevadvisory.com), you agree to be bound by these Terms of Service. If you do not agree, please do not use this website.
2. Nature of Services
MedDev Advisory provides regulatory documentation consulting services including ISO 10993 biological evaluation plans (BEP), biological evaluation reports (BER), toxicological risk assessments (TRA), EU MDR technical file sections, and FDA 510(k) biocompatibility documentation.
Our services are advisory and documentation in nature. We do not act as:
- A notified body or certification body
- A test laboratory
- Legal counsel or regulatory legal representative
- A manufacturer or authorised representative
3. No Guarantee of Regulatory Outcome
Regulatory outcomes depend on many factors outside our control, including device risk class, quality of client-supplied data, testing history, predicate strategy, and reviewer discretion. MedDev Advisory does not guarantee regulatory clearance, CE marking, notified body acceptance, or FDA approval of any submission.
All documentation is prepared to align with current regulatory standards and guidelines to the best of our professional ability, based on information provided by the client.
4. Client Responsibilities
The client is responsible for:
- Providing accurate, complete, and up-to-date device and material information
- Reviewing all deliverables before submission
- Making final regulatory decisions regarding their device
- Ensuring their device complies with all applicable laws and regulations
5. Confidentiality
All device-specific and business information shared with MedDev Advisory is treated as confidential. We do not disclose client information to third parties except where required by law. A formal Non-Disclosure Agreement (NDA) can be signed upon request before project commencement.
6. Intellectual Property
All website content, including text, images, and design elements, is the property of MedDev Advisory and Arvind Rathore. Deliverables produced for clients become the property of the client upon full payment. Educational content on the Resources and Insights pages may not be reproduced without permission.
7. Payment and Revisions
Payment terms, revision rounds, and project scope are agreed upon in writing before each project commences. One revision round is included in standard project fees unless otherwise stated. Additional revisions may be charged separately.
8. Limitation of Liability
To the maximum extent permitted by applicable law, MedDev Advisory shall not be liable for any indirect, incidental, or consequential damages arising from use of our services or website. Our total liability for any claim shall not exceed the fees paid for the specific project in question.
9. Governing Law
These Terms are governed by the laws of India. Any disputes shall be subject to the jurisdiction of courts in Kanpur, Uttar Pradesh, India.
10. Changes to Terms
We reserve the right to update these Terms at any time. The updated date at the top of this page will reflect changes. Continued use of this website constitutes acceptance of the revised Terms.
11. Contact
For any questions about these Terms: arvindrthr0607@gmail.com