Annex 1 Quality policy

The purpose of this Quality Policy is to establish a framework for the ongoing development, implementation, maintenance, and improvement of our Quality Management System (QMS) in accordance with the requirements of ISO 13485:2016, ensuring the safety and effectiveness of our medical devices.

As you may know, we are committed to the design, manufacture, and delivery of medical devices that meet the highest standards of quality, which includes not only patient safety, but also technical aspects such as interoperability of data, privacy of data and ease of use of the devices, regardless of how technically ellaborate they may be.

Review

This Quality Policy will be reviewed in the periodicity specified in the relevant procedure, as part of the Management Review process - or whenever significant changes occur that may impact our QMS or the quality of our products.

Mission

Our main activity is the design, development and marketing of Medical Devices that help HCPs in their work. To achieve this, we use computer vision convolutional neural networks, which offer clinical insights just by looking at images, making our products a useful tool for medical professionals.

Vision

We see a future where computer vision convolutional neural networks are indispensable to HCPs in dermatology, where it is used as a tool to increase the accuracy of HCPs, increase the adequacy of referrals and improve the adhearance to treatments. In this future, citizens enjoy better health and organisations run more efficient and profitable ventures.

Values

Our values are:

Collaboration

Collaboration with healthcare professionals, both to develop and also to divulge our solutions.

Quality

Quality because we thoroughly implement a quality management system based on continuous improvement.

Commitment

Committed to fulfilling the requirements of our customers, to observe current legislation and all regulatory requirements in all our activities, including, but not limited to:

• UNE-EN ISO 13485:2016 Quality management systems. Requirements for regulatory purposes.
• UNE-EN 62304:2007/CORR:2009/A1:2016 Medical device software. Software life cycle processes.
• UNE-EN ISO 14971:2019 Medical devices/health products. Application of risk management to MD.
• UNE-EN ISO 15223-1: 2017 Health products. Symbols to be used on labels, labelling and information to be supplied.
• UNE-EN 1041: 2009/A1:2014 Information provided by the manufacturer of medical devices.
• UNE-EN 62366:2009/A1:2015 Application of usability engineering to medical devices.

As well ass provisions of Council Directive 93/42/EEC for Medical Devices and Regulation (EU) 2017/745 on medical devices, or any other regulation that may be applicable.

Communication

As you can see, we communicate this Quality Policy will to all employees and relevant stakeholders.

It is also available to the public on our website.

However, regarding our employees, irrespective of their role, they are responsible for understanding, implementing, and upholding this Quality Policy. So, if you are an employee, we might ask you to sign this document in proof of receipt and conformity.

Signature
Full name

Signature meaning

The signatures for the approval process of this document can be found in the verified commits at the repository for the QMS. As a reference, the team members who are expected to participate in this document and their roles in the approval process, as defined in Annex I Responsibility Matrix of the GP-001, are:

• Author: Team members involved
• Reviewer: JD-003, JD-004
• Approver: JD-001