The certification, granted by AENOR, consolidates the organisation as a key player in healthcare innovation in Spain, guaranteeing the highest quality standards while supporting companies throughout the entire process, from research to the prototyping of medical devices.
The certification reaffirms Leitat’s positioning as a strategic partner for hospitals and companies in the medical sector and enables Leitat to reduce development times and speed up market access for new medical solutions and technologies.
Leitat Technological Center has obtained the UNE-EN ISO 13485:2018 certification, the international standard that establishes the requirements for a quality management system applied to medical devices and related services.
The certification, awarded by AENOR, recognises Leitat’s excellence and technical reliability in the design and development of medical devices and in vitro diagnostic systems, consolidating it as a European reference in technological solvency in the medical field and as a strategic partner for product development in regulated, market-oriented environments.
This certification provides greater regulatory assurance and traceability, strengthening Leitat’s ability to support companies throughout the entire development cycle, from R&D to industrialisation, in compliance with the most demanding sector regulations.
A step forward in innovation applied to the medical sector
With this milestone, Leitat becomes the first technological centre in Spain to obtain ISO 13485:2018 certification covering the entire design and development cycle of medical devices and in vitro diagnostic systems for third parties, from research to prototyping, across four product typologies. The certified activities are carried out at Leitat’s facilities in Terrassa, DFactory Barcelona and the Parc Científic de Barcelona.
The scope of the ISO 13485 certification granted to Leitat includes:
- Design and engineering of electromedical equipment for diagnosis and therapeutic monitoring for third parties.
- Development of diagnostic support software for in vitro diagnostic devices for third parties.
- Design and development of instruments using additive manufacturing solutions and 3D printing for third parties.
- Development of bioreceptors for in vitro diagnostics for third parties.
From research to market: medical innovation with rigour and purpose
The achievement of ISO 13485:2018 consolidates Leitat as a key agent in technology transfer for the healthcare sector and as a strategic ally to accelerate the time to market of new solutions, medical technologies and in vitro diagnostics, providing rigour, reliability and professionalism at every stage of the process.
With this recognition, Leitat remains committed to innovating with purpose, transforming research into real solutions that improve people’s lives and accelerating their arrival to the market with maximum reliability and guaranteed regulatory compliance.
“This certification recognises the rigour, technical competence and service-oriented vocation that define Leitat. It consolidates us as a trusted technological partner in the medical and biomedical field, offering companies innovations with real impact on people’s health,” stated Jordi Cabrafiga, General Director of the centre.
For his part, Jordi Martín, Director of AENOR in Catalonia, stated: “Leitat’s achievement of the AENOR ISO 13485 certification represents a decisive step in consolidating management systems that guarantee quality and safety in the medical devices sector. This international standard establishes the most demanding requirements for the manufacture and development of medical devices, ensuring robust processes and full traceability. With this certification, Leitat strengthens its commitment to excellence and trust in a field where innovation and reliability are essential for people’s health and wellbeing.”
Quality, safety and trust in the service of innovation
ISO 13485 adds to the set of international certifications and accreditations that endorse Leitat’s technological solvency and its commitment to continuous improvement. The standard, aligned with European Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR), establishes quality requirements applicable to medical devices and related services. Its application provides a presumption of conformity with European regulations and is essential for obtaining CE marking and commercialising products within the European Union.
This achievement is the result of more than a year of collective work within the framework of the DiMεD project (Red Cervera) and strengthens Leitat’s capacity to build trust, establish strategic partnerships and accelerate technology transfer in the healthcare field.
More information about Leitat’s certifications and accreditations: https://leitat.org/certificacions-i-acreditacions
