Complaints Procedure

Last updated: September 16, 2025.

Purpose

We are committed to providing safe, effective, and reliable medical products. This Complaints Procedure sets out how we manage, investigate, and respond to product-related complaints in accordance with our quality management system and applicable regulatory requirements.

How to Submit a Complaint

If you wish to raise a complaint regarding one of our products or services, please contact us via one of the following channels:

Email: enquiries@orthotix.co.uk

Telephone: 029 2037 0696

Postal Address: Orthotix, Unit 1, Sanatorium Road, Cardiff. CF11 8DG

To ensure we can process your complaint efficiently, please include:

Product name, model/lot/serial number (if known)

Detailed description of the issue

Date the issue occurred or was observed

Your contact details

Acknowledgement
We will acknowledge receipt of your complaint within 2 working days.

Investigation
All complaints are reviewed and assessed by our Quality Assurance team. Where required, complaints are escalated to regulatory authorities in line with vigilance reporting obligations. An investigation may involve requesting additional information or product samples to enable a thorough assessment.

Response Timeframes
We aim to provide an initial response within 10 working days. Where a full investigation is required, we will keep you informed of progress and provide updates at appropriate intervals until the case is concluded.

Escalation
If you are not satisfied with the outcome of your complaint, you may request that it be escalated to a senior manager or our Responsible Person for Medical Devices (PRRC) for further review.

Confidentiality & Data Protection
All complaints will be handled confidentially. Personal data will be managed in accordance with data protection legislation and only used for the purpose of investigating and resolving the complaint.

Continuous Improvement
All complaints are recorded and reviewed as part of our quality management system to ensure continuous improvement and regulatory compliance.