Medical Device Quality Policy

At GENELINK S.L. (Vivabioma), 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 in 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: Provide medical devices that meet the highest standards of safety and efficacy, satisfying consumer demand and ensuring full customer satisfaction.

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

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

• Customer Focus: Increase user satisfaction, meeting their expectations and proactively managing any feedback to prevent incidents.

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

• Team Commitment: Foster collaboration and responsibility among all staff, where each member guarantees the quality of their work.

• Sustainability and Environment: Integrate 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 reference framework for establishing and reviewing our annual objectives, ensuring that GENELINK S.L. remains at the forefront of the sector.