MDx Quality Policy

5th May 2025

MDx offers complete life-cycle expert support for medical device and in-vitro diagnostic projects, from quality assurance support with the ISO 13485/15189 certification to IVDR/MDR technical documentation development, as well as the design and management of clinical studies for CE marking or FDA approval. MDx partners with the MedTech industry, Pharmaceutical partners and their subcontractors to provide a wide range of medical device and IVD consulting services, including medical writing services, curated trainings, in country representation services, such as European Authorized Representation and UK Responsible person, quality assurance for medical devices, clinical investigation and clinical performance studies, as well as all aspects of IVDR performance evaluation.

Vision

We believe everyone should have access to innovative medical devices and in vitro diagnostic medical devices. Our vision is to be a driving force in the MedTech industry, creating a world where innovative medical technologies improve the lives of people everywhere.

Mission

Our mission is to assist organizations in bringing their healthcare innovations to market swiftly and effectively, ensuring that patients benefit from the advantages of innovation as soon as possible.

MDx’s quality policy is to consistently exceed the expectations of our clients and organization by providing the highest quality services for each client interaction.  To achieve this, we will:

• Understand and support the needs and goals of our clients and the industry;
• Recognize the influence of our work on improving human health;
• Recruit high-performing team members who are motivated by client success;
• Focus our efforts on providing timely, accurate, and effective services;
• Ensure compliance with applicable regulations and laws;
• Consistently enhance our quality management system;

We are also dedicated to empowering the brightest minds in the Iberian region, fostering their growth as leaders in the MedTech industry. We provide continuous possibilities for development and growth to promote our most valuable asset, our team.

In support of this policy, the Leadership team has developed a series of objectives, which are supported by ongoing monitoring and measurement and are reviewed continuously as part of the business management process.

This quality policy establishes the company’s commitment to maintaining an effective quality management system in line with ISO 13485 and applicable regulatory requirements.