REFERENCE LABORATORY FOR MEDICAL DEVICES TESTING
At the Instituto de Biomecánica (IBV), we are a reference center in medical device and medical device testing. Our laboratory is specialized in evaluating the safety, durability, and functionality of a wide
variety of medical devices, from surgical implants to technical aids and exoskeletons. We are
the only laboratory in Spain accredited by ENAC under the ISO 17025 standard for
surgical implant testing.
We collaborate with manufacturers, research centers and regulatory bodies, ensuring that
each device meets the highest standards and facilitates its certification in accordance with
European Regulation 2017/745 on Medical Devices (MDR). As a testing laboratory, we help ensure medical devices comply with international regulations and are suitable for marketing in the European market.
TESTING LABORATORY ACCREDITED BY ENAC
The IBV testing laboratory has advanced technology to evaluate the biomechanical and mechanical behavior of medical devices and medical devices in real conditions of use, having ENAC accreditation for testing surgical implants with the scope 519/LE 1105.
Our accreditation by ENAC guarantees the technical competence and reliability of the results of our tests, based on international standards such as ISO 7206-4, ISO 14801, ISO 9585 or ASTM F382.
We have high precision equipment to perform fatigue, flexure, compression, impact and durability tests, adapted to the needs of each manufacturer.
In addition, at IBV we not only carry out tests, but we also provide added value. Each evaluation includes:
1 Technical comments
2 Critical analysis of the results.
3 Comparisons of the results with physiological loads and own databases of the behavior of other implants, duly anonymized.
4 Strategic recommendations based on product biomechanics to optimize device design and safety prior to commercialization.
TESTING OF MEDICAL DEVICES AND MEDICAL DEVICES
Our laboratories offer specialized services for the validation and evaluation of different categories of medical devices and medical devices.
We evaluate the mechanical strength, fatigue and stability of surgical implants, including dental implants, articular prostheses and osteosynthesis plates, according to international standards.
We analyze the human-exoskeleton interaction, including comfort, ergonomics, biomechanical efficiency and muscular effort, ensuring its usability and effectiveness in medical and industrial applications.
We perform safety, durability and functionality tests on wheelchairs, orthoses, external prostheses and other assistive devices to ensure their compliance with accessibility and quality standards.
Tell us your needs and we will design a customized testing plan, aligned with regulatory requirements and market demands.
