UKCA Declaration of Conformity

• Name of the device

  DocHQ Physio

• Version number

  1.1

• Date of manufacture

  01/12/2023

• Manufacturer contact details

  HealthHQ Group Limited, First Floor, Teme House, Whittington Road, Whittington, Worcester, Worcestershire, England, WR5 2RY

HealthHQ Group Limited
First Floor, Teme House Whittington Road, Whittington, Worcester, Worcestershire, England, WR5 2RY

declares that under our sole responsibility, the product:

DocHQ Physio V1.1

With the intended purpose to provide exercise-based physiotherapy activities to assess biomechanical function using video capture from a computing platform and where relevant support physical rehabilitation. The software provides physiotherapists with the ability to select condition appropriate physiotherapy and biomechanical function exercises which are performed by the patient. The device provides feedback on exercise technique and performance to the patient during the session. The data on patient biomechanical movement and programme adherence is provided to the physiotherapist to assess patient/client progress and changes in biomechanical function. The software is accessed via a web-based portal.

Meets the provisions of the following UK Regulation(s) required to apply the UKCA Marking:

• Medical Device Regulations 2002 (SI 2002 No.618, as amended) (UKMDR 2002)Risk Classification as per Annex IX
• Class I Active Medical Device (Rule 12)
• Conformity assessment route:Compilation of Technical Documentation, Self-Certification, and Registration with MHRA in accordance with the Medical Device Regulations 2002 (as amended).

The following standards were applied in full:

• EN ISO 13485: 2016+A11:2021 – Medical devices Quality management systems – Requirements for regulatory purposes.
• EN ISO14971:2019+A11:2021 – Medical Devices – Application of Risk Management to Medical Devices.
• EN ISO 15223-1:2021 Medical devices — Symbols to be used information to be supplied by the manufacturer – Part 1: General requirements.
• EN ISO 20417:2021 Medical devices – Information to be provided by the manufacturer.
• EN 62366-1:2015+A1:2020 Medical devices – Application of usability engineering to medical devices.
• EN 62304:2006+A1:2015 Medical Device Software – Software life-cycle processes.
• IEC 82304-1:2016 Health software – Part 1: General requirements for product safety.
• MEDDEV 2.7/1, Rev. 4, Clinical evaluation: Guide for manufacturers and notified bodies (guidance).

This product has been developed, tested and verified in accordance with the designated or state of the art standards listed above and the company internal procedures.

Intended Users

DocHQ Physio is intended for use by adult patients experiencing musculoskeletal (MSK) conditions, and by registered physiotherapists providing remote assessment and treatment. Patients access the service to receive guided exercise and rehabilitation programmes, while physiotherapists use the platform to assess, prescribe, and monitor treatment plans.

Intended Use Environment

DocHQ Physio is intended to be used in a home or remote setting by patients, using a personal device with a camera and internet connection, and in a clinical or home-working setting by physiotherapists delivering care remotely via the platform.

To use DocHQ Physio, patients and physiotherapists require a device (desktop, tablet, or mobile) with a camera, microphone, and a stable internet connection, using an up-to-date web browser.