NAME Pre-compliance testing lab

DESCRIPTION

Osasun-produktuen diseinu integrala, gailu medikoen araudi espezifikoa betez (ISO 13485, IEC 62304, IEC60601, ISO 14971, UL2900), hardwarea, softwarea eta komunikazioak barne. IEC 60601 arauarekin bat datorren pre-compliance barne-testerako gaitasuna, eta homologaziorako laguntza laborategi ziurtatuetan, industrializatzeko.

FIELDS OF APPLICATION

Digital health

Electromedical devices

In-Vitro diagnostics

MOST OUTSTANDING EQUIPMENT AND COMPONENTS

  • Climatic chamber

    Climatic chamber. Equipment that makes it possible to emulate environmental conditions of temperature and humidity to verify that the electronic equipment being designed manages to function in the most extreme possible environments desired. This also makes it possible to carry out tests to accelerate the ageing of electronic equipment.

  • Electromagnetic compatibility testing

    Electromagnetic compatibility testing. Electronic devices generate and are subject to electromagnetic disturbances and load switching in shared networks. The level of interference they generate must be below a threshold, in order to avoid excessive interference to equipment in their environment. Similarly, any electronic device must have minimum immunity levels. By complying with the above two principles, any device can cohabit in the same electronic environment with other equipment. They are said to be electromagnetically compatible. In this sense, Tekniker has a set of equipment that can prove that electronic designs meet these requirements established by the different regulations depending on the application sector.

  • ntegration with operating systems and communications systems

    Integration with operating systems and communications systems. Development of HMIs and BSPs for peripherals. Tools for developing solutions with real-time operating systems such as ThreadX, Mentor Embedded Linux, SafeRTOS, etc.
    Development of graphic HMI solutions using QT Integration of POCT-1A device connectivity protocols over Ethernet or Wifi.
    Integration of Bluetooth connectivity with Health profiles.
    Analysis and cybersecurity solutions for medical devices.

  • Shock and vibration

    Shock and vibration. These make it possible to emulate mechanical disturbances on small equipment. A test bench is available that emulates different vibration conditions that can occur in the working environment of the equipment and for which they must be prepared. It also makes it possible to partially reproduce fall or impact conditions to analyse the degree of robustness of the designs.

  • Tools for embedded solutions

    A set of hardware and software tools for the development of embedded solutions based on ARM, DSP or FPGA CPUs, allowing to meet the needs of electronic development of medical devices with digital processing.

SERVICES OFFERED BY THE ASSET

Analysis of idea / product

Collaboration and co-working (generation of R&D proposals at regional, national and European level)

Collaboration and co-working (generation of R&D proposals at regional, national and European level)

Search for potential partners for a collaborative proposal.

Pre-clinical validation

Realisation of prototypes for validation in relevant environments.

Product Assessment on ISO 13485

Integral development of medical devices and support to the homologation for their industrialisation.

Proof of concept

Realisation of minimum viable products to validate the functionality of key technologies

Strategic advice and support in the (co) development of new products or services (evaluation of ideas, specifications, early dialogue and health technology assessment, etc.)

Elaboration of a detailed state of the art on the technologies involved including intellectual property aspects.

ENTITY MANAGING THE ASSET

ENTITY MANAGING THE ASSET
FUNDACIÓN TEKNIKER
Contact person:
Sabino Azcarate Leturia
sabino.azcarate@tekniker.es