Pre-compliance testing laboratory for medical devices

• Life & Medical Sciences

Tel:+34 943 206 744

A laboratory specialising in the comprehensive design of medical devices in accordance with specific medical device regulations and standards, including ISO 13485, IEC 62304, IEC 60601, ISO 14971 and UL 2900.

Its capabilities cover hardware, software and communications development, as well as in-house pre-compliance testing in accordance with IEC 60601 requirements. The laboratory also provides support for product certification and approval at accredited testing laboratories, facilitating the transition towards industrialisation.

Equipment

• Climatic chamber
• Electromagnetic compatibility (EMC) testing equipment
• Embedded software development and testing tools
• Impact and vibration testing equipment
• Integration with operating systems and communication systems

• Strategic consultancy and guidance in the development and co-development of new products and services, including concept evaluation, specification definition, early-stage dialogue and healthcare technology assessment.
• Collaboration and co-working on the development of R&D proposals at European, national and regional levels.
• Product concept assessment and evaluation.
• Proof-of-concept (PoC) development.
• Product validation in accordance with ISO 13485.
• Technology validation.

TEKNIKER
Technology Park, Iñaki Goenaga, 5, 20600, Eibar (Gipuzkoa)

Testing and Test Facilities:

- Metrology and Inspection Technologies

- Advanced Manufacturing Technologies

Application sectors

• Capital goods and industrial equipment
• Capital goods and mechanical engineering industry
• Electronics and microtechnology
• Pharmaceuticals and genetice
• Healthcare and medical devices

Industry plan

• HAZI · Healthcare and biomedical sector
• IRABAZI · Advanced manufacturing