Terms of Service

These Terms of Service (the “Terms”) constitute an agreement between you, or the organisation you represent (“you”, “your”), and TamRx Ltd, a company registered in England and Wales under company number 16596160 with its registered office at Nexus Innovation Centre, Discovery Way, Leeds, West Yorkshire, LS2 3AA, United Kingdom (“TamRx”, “we”, “us”).

By creating an account, accessing or using the TamRx platform and related services (the “Service”), you agree to these Terms. If you are entering into these Terms on behalf of an organisation, you confirm that you have authority to bind that organisation, and references to “you” include that organisation.

TamRx is a software-as-a-service platform providing AI-assisted regulatory intelligence and document generation for medical devices, software as a medical device (SaMD), artificial intelligence systems in healthcare, and pharmaceutical regulatory affairs, across frameworks including the EU AI Act, EU MDR and IVDR, the UK MHRA regime and the US FDA regime.

The Service provides software tools to assist with regulatory assessments, classification, document drafting, technical documentation support, clinical evaluation support and regulatory research. It is an aid to qualified professional work, not a substitute for it.

The Service provides information and software tools only. It does not provide legal advice, medical advice or regulatory advice, and using it does not create any advisory, professional or fiduciary relationship between you and TamRx.

The Service does not replace, and is not a substitute for, regulatory consultants, notified bodies, competent authorities, legal professionals or your own qualified personnel. You remain responsible for reviewing, validating and approving all outputs before any use, reliance or submission. See our AI Transparency Statement for the specific limitations of the AI components.

TamRx does not guarantee any regulatory outcome, classification, clearance, approval, certification or determination by the FDA, MHRA, any EU notified body, any competent authority or any other body. Confidence levels, probabilities, estimates and scenario analyses provided by the Service are indicative aids to prioritisation only. They are not predictions, assurances or guarantees, and must not be relied upon as such.

To use most features you must create an account using a supported authentication method (Microsoft, Google or email). You are responsible for the accuracy of your registration information, for maintaining the confidentiality of your credentials, and for all activity under your account. You must notify us promptly of any unauthorised use. You must be at least 18 years old and capable of forming a binding contract to use the Service.

The Service is offered on a free tier and on paid subscription plans. The free tier provides a limited allowance of assessments and document exports within a rolling usage window, after which a waiting period applies before further free use, or you may upgrade to a paid plan. We may change free-tier allowances and reasonable fair-use limits from time to time to protect the integrity and availability of the Service.

Paid plans (“TamRx Pro”) are offered on a monthly or annual basis. Fees are stated at the point of purchase. Subscriptions renew automatically for successive periods of the same length unless cancelled before the renewal date. We may change subscription pricing on reasonable notice, with changes taking effect at your next renewal.

Payments are processed by our payment provider, Stripe. We do not receive or store your full payment card details. You authorise us, through Stripe, to charge the applicable fees to your chosen payment method on each renewal.

You may cancel a subscription at any time with effect from the end of the current billing period. On cancellation you retain paid access until that period ends, and you are not charged for subsequent periods.

Where you are a consumer in the United Kingdom, you may have a statutory right to cancel within 14 days under the Consumer Contracts (Information, Cancellation and Additional Charges) Regulations 2013. Where you request that we begin providing the Service during that period and you then cancel, we may charge for the value of the Service supplied up to the point of cancellation. Where the digital service has been fully supplied with your prior express consent and acknowledgement that the cancellation right would be lost, the statutory right to cancel may no longer apply.

Business customers are not consumers and do not have these statutory cancellation rights. For business customers, fees are non-refundable except where required by law or expressly agreed in writing.

You agree to use the Service lawfully and not to: attempt to circumvent usage limits, access controls or security measures; reverse engineer, decompile or extract the underlying models or source other than as permitted by law; resell, sublicense or present the output as independent professional regulatory advice; upload unlawful, infringing or malicious content; or use the Service to develop a competing product. We may suspend access for breach of this section.

You retain all rights in the content and inputs you submit to the Service (“Customer Content”), and in the document drafts you generate for your own use. You grant us a limited licence to process Customer Content solely to operate, secure and improve the Service, as described in our Privacy Policy. You are responsible for ensuring you have the right to submit Customer Content and that it does not include personal data you are not permitted to share.

The Service, including the platform, its interfaces, the Regulatory Transition Network and all underlying software, content and materials, is owned by TamRx Ltd or its licensors and is protected by intellectual property laws. Except for the rights expressly granted to you, no rights are transferred. The TamRx name and logo are trade marks of TamRx Ltd and may not be used without permission.

The Service relies on third-party providers for infrastructure, AI processing, authentication, email and payments. Your use of the Service may be subject to those providers’ terms where relevant. We select reputable providers and govern their processing of personal data through appropriate agreements, as described in our Privacy Policy and Trust Centre.

We aim to provide a reliable Service but do not warrant that it will be uninterrupted, error-free or available at all times. We may modify, suspend or discontinue features, in whole or in part, and will give reasonable notice of material adverse changes where practicable. Planned maintenance and current status information are described in our Trust Centre.

To the fullest extent permitted by law, the Service is provided “as is” and “as available”, without warranties of any kind, whether express or implied, including implied warranties of satisfactory quality, fitness for a particular purpose, accuracy or non-infringement. We do not warrant that the regulatory information or AI-generated output is accurate, complete or current, and you must verify it as described in clause 3.

Nothing in these Terms excludes or limits liability that cannot be excluded or limited under applicable law, including liability for death or personal injury caused by negligence or for fraud.

Subject to that, to the fullest extent permitted by law, TamRx shall not be liable for any indirect, incidental, special or consequential loss, or for any loss of profits, revenue, goodwill, business, or for any regulatory outcome, rejected or delayed submission, or reliance on AI-generated output. Our total aggregate liability arising out of or in connection with the Service in any twelve-month period shall not exceed the total fees you paid for the Service in that period.

If you are a business customer, you agree to indemnify TamRx against losses, liabilities and reasonable costs arising from your breach of these Terms, your misuse of the Service, or your reliance on or use of outputs in breach of clause 3.

You may stop using the Service and close your account at any time. We may suspend or terminate access where you materially breach these Terms, where required by law, or where necessary to protect the Service or other users. On termination, your right to use the Service ends; clauses intended to survive (including 3, 4, 11, 14, 15 and 16) continue to apply.

We may update these Terms from time to time. Where changes are material, we will take reasonable steps to notify you, for example by email or in-product notice. Your continued use of the Service after the effective date of the updated Terms constitutes acceptance. The current version and its effective date are shown at the top of this page.

These Terms and any dispute or claim arising out of or in connection with them are governed by the laws of England and Wales. The courts of England and Wales have exclusive jurisdiction, save that we may seek injunctive relief in any appropriate jurisdiction. We encourage you to contact us first so we can try to resolve any dispute informally.

Questions about these Terms can be sent to legal@tamrx.co.uk, or by post to TamRx Ltd, Nexus Innovation Centre, Discovery Way, Leeds, West Yorkshire, LS2 3AA, United Kingdom. For help using the Service, see Contact & Support.