Quality policy Medical Products

At GENELINK S.L. (tellmeGen), quality and patient safety are the pillars of our activity. We are proud to announce that our Quality Management System has been certified under the international standard ISO 13485:2016 for medical devices.

This certification guarantees the excellence of our processes within the following scope:

"Design, development, and manufacturing of in vitro diagnostic (IVD) medical devices with CE marking, including software for genetic analysis, and distribution of sample collection kits."

Our quality policy is based on the following commitments:

• Excellence and Safety: Providing medical devices that comply with the highest standards of safety and efficacy, satisfying consumer demand and ensuring the full satisfaction of our customers.

• Regulatory Compliance: Ensuring rigorous compliance with regulations applicable to medical devices, as well as any additional requirements voluntarily subscribed to.

• Continuous Improvement: Constantly optimizing the effectiveness of our Quality Management System through controlled processes, providing staff with the necessary resources for their analysis and monitoring.

• Customer Focus: Increasing the satisfaction of our users, meeting their expectations, and proactively managing any feedback to prevent incidents.

• Risk and Opportunity Management: Leveraging challenges as opportunities for learning and improvement, identifying root causes to prevent deviations.

• Team Commitment: Fostering collaboration and responsibility among all personnel, where every member is the guarantor of the quality of their work.

• Sustainability and Environment: Integrating sustainability criteria into our activities, promoting the rational use of resources, adaptation to climate change, and environmental awareness among employees and stakeholders.

This policy is the framework for establishing and reviewing our annual objectives, ensuring that GENELINK S.L. remains at the forefront of the sector.