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.
MedDev Advisory is a professional practice operated by Arvind Rathore in Kanpur, Uttar Pradesh, India. Paid digital resources are offered for professional or business use. If you request an offer for an organisation, you confirm that you are authorised to act for it.
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 disclose it only where required by law or to service providers reasonably necessary for secure hosting, form or email delivery, payment processing, controlled file delivery, support, or professional administration, subject to appropriate confidentiality and security controls. A formal Non-Disclosure Agreement (NDA) can be signed upon request before project commencement.
6. Digital Resources and Educational Products
MedDev Advisory may offer paid or free digital resources, including checklists, templates, toolkits, workbooks, guides, and educational downloads. These resources are provided for professional and business documentation planning, training, gap assessment, and remediation prioritization within the permitted scope of the accepted order-specific licence.
Digital resources do not include consulting, legal/regulatory advice, biological safety determination, toxicological risk assessment, formal expert review, or submission sign-off unless a separate written consulting scope expressly says so.
7. Digital Resource License
Paid digital resources are licensed, not sold. Unless an accepted written offer and order-specific licence state otherwise, a paid resource is licensed for internal use by the purchasing organization. The purchaser may use the files with employees and authorized contractors working for that organization, but may not resell, redistribute, publish, upload, share externally, include them in a public or reusable template library, sublicense them, or transfer the files outside the purchasing organization without written permission from MedDev Advisory.
An accepted order-specific licence may define Practitioner, Organisation, Consultant, Group, or other permitted-use rights. That specific licence controls permitted use for that order where it differs from this default licence.
MedDev Advisory may suspend access while investigating a credible security, payment, unlawful-use, or material licence-breach concern. Except where immediate action is reasonably necessary to protect security, intellectual property, legal compliance, or other customers, licence revocation for breach will follow written notice identifying the breach and a reasonable opportunity to remedy it. A licence will not be revoked merely because MedDev Advisory later changes its commercial policy.
8. Digital Product Refunds
Subject to applicable mandatory rights, change-of-mind refunds are generally not offered after digital delivery or access begins. Duplicate payment, incorrect-product delivery, corrupted files, or an unresolved technical access failure will be investigated and addressed through correction, replacement, credit, or refund as appropriate. The exact delivery, cancellation, and remedy terms for a paid resource are stated in the accepted written offer.
Subject to applicable mandatory rights and the accepted written offer, a full refund issued after delivery, a confirmed payment reversal or chargeback, or a valid licence revocation ends the right to use the affected digital resource. The licence holder must stop operational use and delete working copies, but may retain one non-operational archival copy only where applicable law or a documented quality-system record obligation requires it. A partial refund or credit does not end the licence unless agreed in writing.
9. Intellectual Property
Website content, publications, digital resources, templates, methods, and source files created by MedDev Advisory remain the intellectual property of MedDev Advisory and Arvind Rathore. Third-party names, marks, fonts, icons, images, standards, publications, and other materials remain the property of their respective owners and are used under applicable licences, permissions, or legal exceptions. No third-party ownership is claimed. MedDev Advisory materials are licensed and are not assigned to the purchaser. Ownership of a bespoke client deliverable transfers only where an expressly commissioned consulting scope states that it will transfer after full payment; pre-existing MedDev Advisory materials and licensed publications remain excluded. Educational content on the Resources and Insights pages may not be reproduced without permission.
10. Payment and Revisions
For consulting services, payment terms, revision rounds, and project scope are agreed in writing before work begins. One revision round is included in standard project fees unless otherwise stated. Additional revisions may be charged separately.
For a paid digital resource, the accepted written offer identifies the licence, currency, price, update option, applicable tax treatment, payment route, delivery method, and any buyer-borne bank or intermediary charge. Prices are exclusive of applicable tax unless the offer expressly states otherwise. No payment is due from an availability request alone.
11. 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, digital resources, or website. Our total liability for any claim shall not exceed the fees paid for the specific project, service, or digital-resource order giving rise to that claim.
Nothing in these Terms excludes or limits liability, remedies, or rights that applicable law does not permit the parties to exclude or limit.
12. Governing Law
These Terms are governed by the laws of India. Subject to any mandatory rights or jurisdiction that applicable law preserves, disputes shall be subject to the courts in Kanpur, Uttar Pradesh, India.
13. Changes to Terms
We reserve the right to update these Terms prospectively. The updated date at the top of this page will reflect changes. Continued use of this website may be subject to the revised Terms, but later website changes do not retroactively alter an accepted paid-resource order whose written offer identifies a dated Terms version, unless agreed in writing or required by applicable law.
14. Contact
For any questions about these Terms: arvind.rathore@meddevadvisory.com