Medical devices laboratory

• Engineering & Technology

Tel:+34 943 206 744

Infrastructure for the comprehensive design and development of medical devices in accordance with specific medical device regulations and standards (ISO 13485, IEC 62304, IEC 60601, ISO 14971, UL 2900).

Capabilities include hardware, software and communications development (POCT-1A devices over Ethernet/Wi-Fi, and Bluetooth connectivity using healthcare profiles).

The laboratory provides in-house pre-compliance testing in accordance with IEC 60601 and support for certification at accredited laboratories. Full traceability of the design and verification process is ensured through validated software tools.

Equipment

• Electromagnetic compatibility (EMC) testing equipment
• Environmental testing equipment
• Cybersecurity testing equipment
• Embedded software testing tools
• Specialized medical software for design and verification lifecycle traceability

• Strategic consulting for medical device development in accordance with ISO 13485
• Product concept assessment
• Proof-of-concept development
• Product validation in accordance with ISO 13485
• Technology validation
• Support for certification at accredited laboratories

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

Medical Devices and Neuroengineering:

- Electronics and Embedded Systems

- Advanced Manufacturing Technologies

Application sectors

• Healthcare and medical devices
• Advanced digital solutions

Industry plan

• HAZI · Healthcare and Biomedicine