Terms of Service

1. Scope of Services

VerityNodes Ltd provides the following categories of service to medical device manufacturers and healthtech companies:

• Regulatory Readiness Audit — assessment of compliance documentation against target market requirements, delivered as a gap report
• Regulatory Intelligence Retainer — monthly monitoring of regulatory developments across FDA, EU MDR, and UK MDR frameworks, delivered as briefing reports
• Clinical Evidence Documentation — drafting of clinical evaluation plans, CER sections, evidence gap analyses, PMCF plans, and clinical white papers
• Free regulatory guides and resources — publicly available reference content published at veritynodes.ai

The specific scope of each paid engagement is defined in an individual project agreement or engagement letter, which takes precedence over these general terms where there is any conflict.

2. Not Regulated Advice — Important Disclaimer

VerityNodes Ltd provides regulatory intelligence and documentation drafting support. Our services do not constitute regulated legal advice, regulated regulatory affairs advice, or clinical advice.

• We are not a notified body and do not certify devices or issue CE certificates
• We are not a regulatory law firm and do not provide legal opinions
• Clinical evaluation reports we draft require review and sign-off by the manufacturer's Qualified Person or a suitably qualified clinical expert
• All regulatory submissions and compliance decisions remain the sole responsibility of the manufacturer
• Our regulatory guides and free resources are provided for informational purposes and do not constitute advice specific to your device or regulatory situation

Guidance we provide reflects our understanding of the regulatory frameworks referenced at the time of delivery. Regulations and guidance documents change. We recommend verifying all requirements against current source documents and, where significant commercial decisions depend on regulatory interpretation, seeking independent professional advice.

3. Engagement Terms

Paid engagements commence upon execution of a project agreement or engagement letter signed by both parties. No work will begin and no invoice will be raised until scope and price have been confirmed in writing.

• Fixed-price projects (Regulatory Readiness Audit, Clinical Evidence Documentation) — the agreed price covers the scope defined in the engagement letter. Out-of-scope work is subject to separate agreement
• Monthly retainers (Regulatory Intelligence Retainer) — the monthly fee is invoiced at the start of each calendar month. The minimum engagement term is three months. After the minimum term, either party may terminate with 30 days written notice
• One revision round is included in all fixed-price documentation deliverables. Additional revision rounds are subject to separate scoping and pricing

4. Payment Terms

• Invoices are payable within 14 days of the invoice date unless otherwise agreed in writing
• Payment is accepted by bank transfer. Invoice details will be provided in each invoice
• For fixed-price projects, a 50% deposit is required before work commences. The balance is due on delivery of the final deliverable
• Late payment may attract statutory interest under the Late Payment of Commercial Debts (Interest) Act 1998 at 8% above the Bank of England base rate
• All prices are quoted in USD unless otherwise agreed. VerityNodes Ltd is not currently VAT registered. If VAT registration status changes, clients will be notified in advance

5. Intellectual Property

Upon receipt of full payment for a completed engagement, VerityNodes Ltd assigns to the client full ownership of the specific deliverables produced for that engagement — including audit reports, CER sections, briefing reports, and other drafted documents.

VerityNodes Ltd retains ownership of:

• Our methodologies, templates, frameworks, and working processes
• All content published on veritynodes.ai including regulatory guides, articles, and free resources
• The VerityNodes brand, logo, and all associated intellectual property

Clients may not reproduce, distribute, or publish VerityNodes deliverables as their own original intellectual property or in a way that misrepresents their origin.

6. Confidentiality

VerityNodes Ltd treats all client technical documentation, device information, and business information as strictly confidential. We will not disclose client information to any third party except as required to deliver the services (for example, using secure cloud storage) or as required by law.

Client technical files and documentation shared with VerityNodes for service delivery are stored in access-controlled environments and deleted within 30 days of project completion unless the client requests earlier deletion.

An NDA is available on request before any documentation is shared. Where a client requests an NDA, work will not begin until the NDA is executed.

7. Limitation of Liability

To the maximum extent permitted by law, VerityNodes Ltd's total liability to any client for any claim arising from or relating to our services shall not exceed the total fees paid by that client in the three months preceding the claim.

VerityNodes Ltd shall not be liable for:

• Any indirect, consequential, or economic loss including loss of revenue, loss of anticipated savings, or loss of business opportunity
• Any regulatory non-conformity, submission failure, or enforcement action arising from a client's use of our deliverables
• Any inaccuracy in our regulatory intelligence caused by changes in regulation or guidance after the delivery date
• Any loss arising from the client's failure to seek independent professional advice where appropriate

Nothing in these terms limits liability for death or personal injury caused by negligence, fraud, or any other liability that cannot be excluded by law.

VerityNodes Ltd holds professional indemnity insurance. Details are available on request.

8. Termination

• Fixed-price projects — either party may terminate with written notice. Where the client terminates after work has commenced, fees for work completed to the point of termination are due. The deposit is non-refundable after work has begun
• Monthly retainers — either party may terminate after the minimum three-month term with 30 days written notice. The final month's fee is due in full regardless of when notice is given within that month
• VerityNodes Ltd reserves the right to terminate any engagement immediately if a client requests work that falls outside the scope described in these terms or that would require us to provide regulated advice

9. Governing Law

These terms and any engagement undertaken by VerityNodes Ltd are governed by the law of England and Wales. Any disputes shall be subject to the exclusive jurisdiction of the courts of England and Wales.

These terms were last reviewed in April 2025. We may update them from time to time. The current version is always published at veritynodes.ai/terms. Continued use of our services after an update constitutes acceptance of the revised terms.

10. Contact