DESCRIPTION
Tekniker is a technology centre specialising in Advanced Manufacturing, Surface Engineering, Product Engineering and ICT for manufacturing.
Its mission is to provide growth and welfare through R&D&I to society as a whole, contributing in a sustainable way to the competitiveness of the business fabric as a whole. Tekniker is a member of the Basque Research and Technology Alliance (BRTA).
We are transferring this capacity for complex mechatronic developments to the health sector as an integral supplier of software, electronics, sensors and mechatronic systems in medical devices, in accordance with European and American standards.
The areas of work are:
- Electromedical devices
- Point of Care devices
- Development of diagnostic and detection equipment
- Manufacture of biomedical components
- Digital Health
- Experience under medical standards, including software development under ISO62304
- In-house pre-compliance testing capability according to IEC60601
Tekniker is certified ISO 13485:2016 (ES21/209075) for the design and development of R&D projects for medical devices.
Keywords
Health 4.0, Medical devices, Design and development of medical devices, Tissue engineering, Healthcare products, Biomarker sensors and detectors, In vitro diagnosis, Telemedicine, ISO 13485, IEC 62034, IEC 60601
