Vicomtech obtains the ISO-13485 certification, guaranteeing its capacity for the design and development of software and Artificial Intelligence in the field of medical devices.

ISO 13485 is the standard that ensures the quality criteria necessary for the development of safe medical devices for patients, meeting the requirements of our customers and the applicable legal requirements, such as those related to the new European Medical Device Regulation (MDR), which regulates the specificity of software medical devices.

With this new certification, we intend to make it easier for our customers, as technology developers, to bring to market products that require this certification, in particular healthcare software, artificial intelligence components or systems with digital components that assist in clinical decision making for diagnostic, therapeutic or other purposes.

Furthermore, in a changing regulatory environment, we are the first technology center in Spain to address the specificity of medical devices with artificial intelligence, establishing criteria for their development and incremental validation in clinical settings. These changes also prepare us for the future AI Act, where these products are considered high-risk AI components due to their orientation for use with patients.

This recognition reinforces our ability to continue collaborating with our customers and partners in the development of innovative, safe and regulatory compliant solutions.

In addition, at Vicomtech, committed to technological innovation applied to Artificial Intelligence and healthcare software, we are always looking to improve the quality of life of patients through tools that optimize processes and results in healthcare.

We have been working in the healthcare environment for years, developing cutting-edge technological solutions that drive digital transformation in healthcare. This certification reinforces our commitment to the safety and quality of each of our developments, consolidating our position as a benchmark in the sector.

With this new achievement, we continue to advance our mission to deliver innovative technology solutions to the biomedical industry that make a real difference in the lives of patients, facilitate the work of clinicians and optimize healthcare environments and systems.