Case Services Terms

Arch•OS is a trading name of 21D Clinical Limited ("Arch OS", "we", "us"), a company registered in England and Wales under company number 09476584, registered office Unit 602 Birchwood One Business Park, Dewhurst Road, Birchwood, Warrington, England, WA3 7GB. Arch•OS is our AI-assisted, full-arch implant restoration design and lab service.

• Case: one patient treatment order submitted by the Practice, with its prescription and records.
• Case Portal: our secure online channel for submitting Cases, reviewing proposed designs view-only, commenting and approving.
• Design: the proposed treatment design, surgical-guide design or prosthetic design we prepare for a Case.
• Device: a custom-made surgical guide, provisional or final prosthesis, or related component we supply for a Case.
• Prescriber: a registered dental professional at the Practice who prescribes and approves a Case.
• Practice: the dental-practice legal entity that accepts these Terms.
• Patient Data: personal data, including health data, about a patient or prospective patient that the Practice submits for a Case.

1. For each Case, we prepare a Design from the Practice's prescription and records, present it for review in the Case Portal, and, once approved, manufacture or arrange manufacture of the Devices.
2. Our designers use our proprietary in-house platform, including AI-assisted tools, to prepare Designs. The platform and its AI are used only by Arch OS personnel. We do not license, sell or supply the platform or its AI to the Practice or anyone else.
3. Devices are custom-made devices made to the Prescriber's written prescription. We are the manufacturer of record. In the UK we act as a custom-made device manufacturer registered with the MHRA. In the US we act as specification developer [subject to confirmation].
4. We supply each Device with a custom-made device statement and the identification and traceability information required by law.
5. Devices are made only from materials and components that are cleared or compliant for their intended use in the market where the Case is treated.
6. Case services are available in the United Kingdom, the United States and the United Arab Emirates. Availability elsewhere is subject to regulatory confirmation.

1. The Case Portal lets Authorised Users submit Cases and records, review proposed Designs in a view-only 3D view, comment, request changes, and approve or reject Designs by e-signature with an audit trail.
2. The Case Portal is a communication and approval channel. It is not a planning, design, measurement or diagnostic tool, and it does not provide clinical findings.
3. We grant no licence to any software. The Practice may use the Case Portal only to place and manage its own Cases.
4. The Practice must ensure each Authorised User is appropriately registered, trained and authorised; keep credentials confidential; remove access promptly when a user leaves; and tell us promptly about any suspected unauthorised access.

1. The Prescriber is responsible for diagnosis, patient assessment, treatment selection, informed consent, the prescription and every clinical decision.
2. A Design is a proposal prepared to the Prescriber's prescription. It is not a diagnosis, a confirmation of patient suitability or a guarantee of outcome.
3. We will not manufacture a Device until the Prescriber has approved the final Design in the Case Portal. Approval confirms the Prescriber has reviewed the Design against the patient's records and accepts it for clinical use.
4. The Prescriber must check every Device before use and must not use a Device that appears damaged, incorrect or unsuitable. Tell us within [5] working days of delivery.

1. The Practice must supply accurate, complete and current records suitable for the Case, including CBCT, intraoral scans, photographs, medical history and prescription.
2. The Practice must submit records only through the Case Portal or another secure method we approve.
3. We may rely on the records supplied unless an error is reasonably apparent. We will tell the Prescriber if records are insufficient to prepare a Design.

1. We operate a quality management system [aligned with / certified to] ISO 13485, including controls over our suppliers and manufacturing processes.
2. The Practice must report to us promptly any Device problem, complaint, adverse event or near miss, and help us investigate it. We report incidents to regulators where required.
3. We keep Case and Device records for the periods the law requires.

We own all rights in our platform, AI models, methods, Designs, design files and know-how. The Practice may use the Designs and Devices supplied for a Case only for the treatment of that patient and for its clinical records. Design files are not supplied for manufacture by others unless we agree in writing.

Prices, payment terms, delivery times, remakes and warranties are set out in our current price list or Order Schedule, which forms part of these Terms.

Each party must protect the other's confidential information, use it only for these Terms and disclose it only to people who need it and are bound by confidentiality. Legal or regulatory disclosure is permitted.

1. For Patient Data, the Practice is the controller and we are its processor, except where the law makes us a controller in our own right (for example, Device records and incident reporting). Schedule 1 applies to our processing as processor.
2. We are an independent controller for account administration, Case Portal security, quality and regulatory records, and legal claims. Our Privacy Notice explains this.
3. Where the Practice is a US covered entity, the parties will sign a HIPAA Business Associate Agreement before any protected health information is submitted.

1. Nothing limits liability for death or personal injury caused by negligence, fraud, or any liability that cannot lawfully be limited.
2. We are not liable for loss caused by a clinical decision, inaccurate or incomplete records, a Device used after an apparent defect, or use contrary to our instructions.
3. Subject to clause 12.1, neither party is liable for indirect or consequential loss, or loss of profit, revenue or goodwill. Our total liability for each Case is limited to [the price paid for that Case / amount].

We may suspend Case Portal access to protect patients, data or the service, or to comply with law. Either party may end these Terms on 30 days' written notice, or immediately for a material breach not fixed within 14 days of notice. Cases already approved will be completed unless the law prevents it.

The parties are independent businesses. These Terms, the Order Schedule and Schedule 1 are the entire agreement about Case services. Changes must be in writing. The law of England and Wales governs these Terms, and the courts of England and Wales have exclusive jurisdiction.

• Subject and purpose: receiving, storing and using Patient Data to prepare Designs, manufacture Devices, support Case review and approval, and provide support.
• Duration: while Cases are active and afterwards for return, deletion, backup cycles and legally required retention (including Device records).
• Data subjects: the Practice's patients and prospective patients, and Practice personnel.
• Data: identifiers, contact details, photographs, facial scans, CBCT and radiographs, intraoral scans, medical and dental history, prescriptions, approvals and Case communications. Includes health data.
• Our obligations: process only on documented instructions; confidentiality of personnel; appropriate security; sub-processors only with authorisation and equivalent terms (list in the Privacy Notice); assist with data-subject rights, breaches and DPIAs; notify personal-data breaches without undue delay; allow proportionate audits; lawful international transfers only; return or delete Patient Data at the end of processing unless the law requires retention.
• Practice obligations: give patients the required privacy information, have a lawful basis and an Article 9 condition (or HIPAA authorisation where relevant), and submit only data needed for the Case.