Terms & Conditions

These Terms & Conditions (“Terms”) govern your use of the services, products, and clinic portal provided by Realta Labs (“we”, “us”, “our”). By registering for an account, placing an order, or using our portal, you agree to be bound by these Terms. If you do not agree to these Terms, you must not use the Service.

1. Company Information

• Company: Realta Labs (a trading name of Realta Labs Ltd)
• Location: Co. Down, Northern Ireland
• Email: hello@realtalabs.com

These Terms are governed by the laws of Northern Ireland and the United Kingdom.

2. Definitions

• “Clinic” or “you” means the registered partner clinic, including its authorised practitioners and administrators.
• “Device” means a custom foot orthotic manufactured by Realta Labs to a clinician's prescription.
• “Portal” means the Realta Labs clinical ordering platform accessible at www.realtalabs.com.
• “Service” means the website, the Portal, and all related orthotic manufacturing and delivery services.
• “Order” means a request submitted through the Portal for the manufacture of one or more Devices.

3. Eligibility and Regulatory Compliance

The Service is available only to registered healthcare professionals. By registering for the Service, you confirm that:

• You are a registered healthcare professional with appropriate HCPC registration (or equivalent recognised professional body registration) valid for the jurisdiction in which you practise.
• You will maintain your professional registration for the duration of your use of the Service.
• You will notify us immediately if your professional registration lapses, is suspended, or is subject to conditions.
• All prescriptions submitted through the Portal are made within your scope of professional practice and competence.

4. Medical Device Classification

Custom foot orthoses manufactured by Realta Labs are classified as Class I custom-made medical devices under the UK Medical Devices Regulations 2002 (as amended). Each Device is manufactured to a registered healthcare professional's prescription for a named patient.

CE/UKCA marking is not required for custom-made devices; however, we maintain a Declaration of Conformity and technical documentation as required by the regulations.

5. Product Warranty

5.1 Shell Warranty

We offer a 5-year shell warranty against fracture under normal use conditions, commencing from the date of dispatch.

5.2 What the Warranty Covers

• Manufacturing defects in the PA11 nylon shell.
• Structural failure of the shell under normal use.
• Delamination.

5.3 What the Warranty Does NOT Cover

• Deliberate damage or fracture.
• Modification of the Device by the clinic, the patient, or any third party (see Section 5.6).
• Normal wear and tear to top covers and posting materials.
• Damage from exposure to extreme heat (above 80°C).
• Chemical damage.
• Devices manufactured from scans that did not meet minimum quality standards where the clinic elected to proceed despite a quality warning.

5.4 Top Covers

Top covers are consumable components. Normal wear is expected, and replacement top covers are available on request.

5.5 Remake Policy

Remakes due to manufacturing error — where the finished Device does not match the submitted prescription — are provided at no charge. The original Device must be returned to Realta Labs for inspection before a manufacturing-error remake is approved.

Remakes requested due to a change in prescription or corrections — for example, the clinician wants a different skive, different posting, or a different arch profile — are chargeable as a new order. If we made it wrong, the remake is free. If the clinician changes their mind or adjusts the prescription, it is a new chargeable order.

Remakes due to poor scan quality, where the scan was accepted and processed in good faith, are chargeable.

All remake requests must be submitted within 30 days of receipt of the original Device.

5.6 Modification of Devices

Any modification, alteration, grinding, heating, or physical adjustment to the delivered Device by the clinic, the patient, or any third party shall immediately void the warranty. Realta Labs accepts no liability whatsoever for Devices that have been modified after delivery.

6. Ordering and Scanning Requirements

• Orders placed via the Portal constitute a contract between Realta Labs and the registered partner clinic.
• Prescription accuracy is the sole responsibility of the submitting clinician.
• Scan quality: scans must be taken in accordance with best practice guidelines provided during onboarding. We reserve the right to reject scans that do not meet minimum quality standards and to request a re-scan. Poor quality scans may result in suboptimal Devices for which we accept no liability.
• Pricing is as per individual clinic partnership agreements and is not displayed publicly.
• Payment terms are as per individual clinic agreements.
• Standard turnaround time is estimated at 5–7 working days from prescription approval. This is an estimate only and is not a guaranteed delivery time.
• Turnaround times are subject to current order volume, production capacity, and scheduling.
• Delays may occur during normal holiday periods, including Christmas, Easter, and bank holidays.
• Supply chain disruptions — including PA11 nylon powder availability, equipment maintenance, and Formlabs consumables — may affect production timelines.
• We will communicate any expected delays to the ordering clinic as soon as reasonably practicable.
• Realta Labs accepts no liability for any losses arising from delivery delays.

7. Return of Goods

Custom foot orthoses are manufactured to the individual prescription submitted by the ordering clinician. As custom-made goods, they are exempt from the Consumer Contracts (Information, Cancellation and Additional Charges) Regulations 2013 — the 14-day cooling-off period does not apply to bespoke or custom-made products. Once an Order has been accepted and manufacturing has commenced, it cannot be cancelled.

This does not affect your right to a remake under Section 5.5 where the Device does not match the submitted prescription, nor any warranty claims under Section 5.

8. Liability and Clinical Responsibility

Realta Labs manufactures custom orthoses to the specification prescribed by the ordering clinician. It is important that all parties understand the following:

• The prescribing clinician is solely responsible for clinical assessment, diagnosis, and prescription decisions.
• We accept no liability for personal injury, adverse clinical outcomes, or patient complaints arising from the clinical prescription decisions made by the ordering practitioner.
• Patients experiencing pain, discomfort, or suspecting a product fault should contact their prescribing clinician immediately — not Realta Labs.

8.1 Prescribing Clinician Responsibilities

The ordering clinician is solely responsible for the following at the point of dispensing and fitting:

• Providing appropriate break-in advice to the patient, including gradual wear-in schedules tailored to the individual.
• Explaining the risks and benefits of custom orthotic therapy to the patient before dispensing.
• Obtaining informed consent from the patient for orthotic treatment.
• Establishing a contact policy — ensuring the patient knows how and when to contact the clinic if they experience pain, discomfort, skin irritation, or any adverse reaction.
• Conducting a fitting assessment at the point of dispensing to verify the Device fits as prescribed.
• Providing footwear advice appropriate to the prescribed Device (e.g. lace-up shoes for CONTROL chassis, appropriate shoe volume for FIT chassis).
• Scheduling appropriate follow-up appointments to assess Device efficacy and patient tolerance.
• Documenting the clinical rationale for the prescription in their own patient records.
• Reporting any suspected adverse incidents related to the Device to both Realta Labs and the MHRA (Medicines and Healthcare products Regulatory Agency) as required under medical device vigilance regulations.
• Ensuring they hold appropriate professional indemnity insurance covering their prescribing and dispensing activities.
• Maintaining their own HCPC registration (or equivalent regulatory body registration) throughout the duration of their partnership with Realta Labs.

8.2 Realta Labs as Manufacturer

Realta Labs is a manufacturer, not a prescriber. We manufacture custom orthoses precisely to the submitted prescription. We do not provide clinical advice to patients and accept no responsibility for:

• The clinical appropriateness of the prescription.
• Patient compliance with break-in advice.
• Adverse outcomes resulting from inadequate fitting, follow-up, or patient instruction.
• Any failure by the clinician to provide appropriate break-in advice, risks/benefits information, or contact arrangements.

8.3 Limitation of Liability

To the maximum extent permitted by law, the total aggregate liability of Realta Labs under or in connection with these Terms, whether in contract, tort (including negligence), breach of statutory duty, or otherwise, shall not exceed the total fees paid by the Clinic to Realta Labs in the 12 months immediately preceding the event giving rise to the claim.

Nothing in these Terms excludes or limits our liability for: (a) death or personal injury caused by our negligence; (b) fraud or fraudulent misrepresentation; or (c) any other liability that cannot be excluded or limited by applicable law.

8.4 Indemnification

The Clinic shall indemnify and hold harmless Realta Labs, its directors, officers, and employees against any and all claims, damages, losses, costs, and expenses (including reasonable legal fees) arising from or in connection with: (a) the Clinic's clinical decisions, prescription errors, or misdiagnosis; (b) misuse of the Device by the Clinic or the patient; (c) any modification of the Device after delivery; or (d) any breach of these Terms by the Clinic.

9. Force Majeure

Realta Labs shall not be liable for any delay or failure to perform its obligations under these Terms where such delay or failure results from events beyond our reasonable control, including but not limited to: acts of God, pandemic or epidemic, fire, flood, storm, industrial action, supply chain disruption, equipment failure, power failure, internet or telecommunications failure, government action or regulation, or any other event of force majeure. In such circumstances, the time for performance shall be extended by a period equivalent to the duration of the force majeure event.

10. Intellectual Property

• All orthotic designs, shell geometries, and lattice structures are the intellectual property of Realta Labs.
• Scan files uploaded by partner clinics remain the property of the submitting clinic.
• The Realta brand, logo, and all website content are protected by intellectual property law.

11. Clinic Portal Terms

• Account credentials are confidential. Clinics are responsible for securing their login details and for all activity under their account.
• One account per practitioner is recommended to maintain traceability.
• We reserve the right to suspend or terminate accounts for misuse or breach of these Terms.
• We aim for 99.9% portal uptime but do not guarantee uninterrupted service. Scheduled maintenance windows will be communicated in advance where possible.

12. Fair Use

• The Portal is for legitimate clinical use only.
• Bulk ordering without corresponding patient prescriptions is prohibited.
• We reserve the right to review ordering patterns and to query orders that appear inconsistent with normal clinical use.

13. Confidentiality

Both parties agree to keep confidential any commercially sensitive information disclosed by the other party in connection with the Service, including but not limited to pricing, business processes, technical specifications, and proprietary manufacturing methods. This obligation survives termination of the agreement and shall continue for a period of five years following termination.

Confidential information does not include information that: (a) is or becomes publicly available through no fault of the receiving party; (b) was already in the possession of the receiving party without restriction; (c) is independently developed without use of the disclosing party's information; or (d) is required to be disclosed by law or regulation.

14. Product Recall

In the unlikely event of a product recall under medical device regulations, the Clinic agrees to cooperate fully with Realta Labs in facilitating the recall. This includes using reasonable endeavours to contact affected patients, providing records of Device allocation, and facilitating the return or safe disposal of recalled Devices. Realta Labs shall bear the reasonable costs of any recall initiated due to a manufacturing defect.

15. Record Keeping

In accordance with medical device regulations (UK MDR 2002 and MDR 2017/745), Realta Labs maintains production records for each Device for a minimum of 10 years from the date of manufacture. These records include the prescription, scan data, manufacturing parameters, materials used, and batch traceability information.

16. Insurance

Realta Labs maintains product liability insurance appropriate for the manufacture of Class I custom-made medical devices. Evidence of insurance is available to partner clinics upon request.

17. Data Protection

Both parties shall comply with all applicable data protection legislation including the UK GDPR and the Data Protection Act 2018. Full details of how we collect, process, and protect personal data are set out in our Privacy Policy, which forms part of these Terms. Partner clinics acting as data controllers for patient data should ensure they have appropriate legal bases and patient-facing privacy notices in place.

18. Complaints Procedure

We take all complaints seriously and aim to resolve them promptly. Our complaints procedure is as follows:

1. Step 1 — Initial contact: please email your complaint to hello@realtalabs.com. We will acknowledge receipt within 2 working days and aim to resolve the matter within 10 working days.
2. Step 2 — Escalation: if you are not satisfied with the initial response, you may escalate the complaint directly to Paul McMullan, Founder and Clinical Director, by writing to hello@realtalabs.com marked “FAO Paul McMullan — Complaint Escalation”.
3. Step 3 — Mediation: if the complaint remains unresolved, either party may refer the matter to mediation through a mutually agreed mediator.
4. Step 4 — Legal proceedings: if mediation does not resolve the matter, either party may commence legal proceedings in the courts of Northern Ireland.

19. Dispute Resolution and Governing Law

These Terms shall be governed by and construed in accordance with the laws of Northern Ireland. The courts of Northern Ireland shall have exclusive jurisdiction over any dispute arising out of or in connection with these Terms. We encourage resolution through direct communication and the complaints procedure in Section 18 before formal proceedings are commenced.

20. Anti-Bribery

Both parties shall comply with the Bribery Act 2010 and all applicable anti-bribery and anti-corruption laws. Neither party shall offer, promise, give, or accept any bribe or other improper advantage in connection with the Service or these Terms. Any breach of this clause shall constitute a material breach entitling the non-breaching party to terminate immediately.

21. Modern Slavery Act 2015

Realta Labs is committed to ensuring that there is no modern slavery or human trafficking in our supply chains or in any part of our business. We comply with the Modern Slavery Act 2015 and expect the same commitment from our suppliers and partners. We conduct due diligence on our supply chain and maintain appropriate records.

22. Notices

All formal notices under these Terms shall be in writing and delivered by email or by post to the following addresses:

• Email: hello@realtalabs.com
• Post: Realta Labs, Co. Down, Northern Ireland

Notices sent by email shall be deemed received on the next business day. Notices sent by post shall be deemed received three business days after posting.

23. Assignment

The Clinic may not assign, transfer, or sub-contract any of its rights or obligations under these Terms without the prior written consent of Realta Labs. Realta Labs may assign its rights and obligations under these Terms to a successor or affiliate upon written notice to the Clinic.

24. Severability

If any provision of these Terms is found to be invalid, unenforceable, or illegal by a court of competent jurisdiction, the remaining provisions shall continue in full force and effect. The invalid provision shall be deemed modified to the minimum extent necessary to make it valid and enforceable while preserving its original intent.

25. Entire Agreement

These Terms, together with our Privacy Policy and any individual clinic partnership agreement, constitute the entire agreement between the parties in relation to the subject matter hereof. These Terms supersede all prior agreements, representations, warranties, and understandings, whether written or oral, relating to the subject matter.

26. Waiver

The failure of either party to enforce any right or provision of these Terms shall not constitute a waiver of such right or provision. A waiver of any right or remedy under these Terms shall only be effective if given in writing and shall not be deemed a waiver of any subsequent right or remedy.

27. Changes to These Terms

We may update these Terms from time to time. Partner clinics will be notified of material changes via email with at least 30 days' notice. Continued use of the Portal after the effective date of the updated Terms constitutes acceptance of those Terms. If you do not agree with the changes, you must cease using the Service and notify us in writing.