{"id":107696,"date":"2025-12-02T12:57:57","date_gmt":"2025-12-02T11:57:57","guid":{"rendered":"https:\/\/www.pcb.ub.edu\/leitat-becomes-the-first-technology-center-certified-with-iso-13485-for-medical-devices-and-related-services\/"},"modified":"2025-12-02T12:57:57","modified_gmt":"2025-12-02T11:57:57","slug":"leitat-becomes-the-first-technology-center-certified-with-iso-13485-for-medical-devices-and-related-services","status":"publish","type":"post","link":"https:\/\/www.pcb.ub.edu\/en\/leitat-becomes-the-first-technology-center-certified-with-iso-13485-for-medical-devices-and-related-services\/","title":{"rendered":"Leitat becomes the first technology center certified with ISO 13485 for medical devices and related services"},"content":{"rendered":"

The technology centre Leitat has obtained the UNE-EN ISO 13485:2018 certification, an international standard that sets out the requirements for a quality management system applied to medical devices and related services. With this achievement, it becomes the first technology centre in Spain to obtain this certification for the entire cycle of design and development of medical devices and in vitro<\/em> diagnostic devices for third parties, from research to prototyping, covering four product types. These activities are carried out at Leitat\u2019s Biomed Division<\/a> in the Barcelona Science Park.<\/strong><\/p>\n

The certification, awarded by AENOR, recognizes the institution\u2019s excellence and expertise in the design and development of medical devices and in vitro diagnostic systems, consolidating its position as a European benchmark for technological reliability in the medical field and as a strategic partner for the development of products in regulated, market-oriented environments.<\/p>\n

This validation allows Leitat to provide greater regulatory assurance and traceability, strengthening its ability to support companies throughout the entire development cycle, from R&D to industrialization, while complying with the most stringent industry regulations.<\/p>\n

From research to market: medical innovation with rigour and purpose<\/strong><\/h3>\n

Obtaining ISO 13485:2018 consolidates Leitat as a key player in technology transfer for the healthcare sector and as a strategic partner to accelerate the time-to-market of new solutions, medical technologies, and in vitro diagnostics, bringing rigor, reliability, and professionalism to every stage of the process.<\/p>\n

With this recognition, Leitat remains committed to innovating with purpose, transforming research into real solutions that improve people\u2019s lives and accelerating their arrival in the market with the highest reliability and regulatory compliance.<\/p>\n

\u201cThis certification recognizes the rigour, technical competence, and service-oriented approach that define Leitat. It consolidates our position as a trusted technological partner in the medical and biomedical fields, offering companies innovations with a real impact on people\u2019s health,\u201d said Jordi Cabrafiga<\/strong>, General Director of the centre.<\/p>\n

For his part, Jordi Mart\u00edn<\/strong>, Director of AENOR in Catalonia, stated: \u201cLeitat\u2019s attainment of the AENOR ISO 13485 certification represents a decisive step in consolidating management systems that ensure quality and safety in the medical device sector. This international standard establishes the most stringent requirements for the manufacturing and development of medical devices, ensuring robust processes and full traceability. With this certification, Leitat reinforces its commitment to excellence and trust in a field where innovation and reliability are essential for people\u2019s health and well-being.\u201d<\/p>\n

Quality, safety, and trust in the service of innovation<\/strong><\/h3>\n

ISO 13485 joins Leitat\u2019s suite of international certifications and accreditations that validate its technological reliability and commitment to continuous improvement. The standard, aligned with the European regulations (EU) 2017\/745 (MDR) and (EU) 2017\/746 (IVDR), sets out quality requirements applicable to medical devices and related services. Its implementation provides a presumption of conformity with European legislation and is essential for obtaining CE marking and marketing products within the European Union.<\/p>\n

This achievement is the result of more than a year of collective work within the framework of the DiM\u03b5D project (Red Cervera) and reinforces Leitat\u2019s capacity to build trust, establish strategic alliances, and accelerate technology transfer in the healthcare sector.<\/p>\n

\u00bb Link to the news:<\/strong> Leitat website [+]<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

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