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.

Our value

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.

SURGICAL IMPLANT TESTING

We evaluate the mechanical strength, fatigue and stability of surgical implants, including dental implants, articular prostheses and osteosynthesis plates, according to international standards.

TESTING OF EXOSKELETONS

We analyze the human-exoskeleton interaction, including comfort, ergonomics, biomechanical efficiency and muscular effort, ensuring its usability and effectiveness in medical and industrial applications.

TESTING OF TECHNICAL AIDS

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.

Shall we talk?

Tell us your needs and we will design a customized testing plan, aligned with regulatory requirements and market demands.

Frequently Asked Questions

Which medical device testing laboratory provides complete assurance of quality and reliability in accordance with international standards?

The Institute of Biomechanics (IBV) provides full assurance of quality and reliability, being the only laboratory in Spain accredited by ENAC under the ISO/IEC 17025 standard for testing of surgical implants. Its accreditation (519/LE 1105) guarantees technical competence and the validity of results, in full compliance with the most demanding international standards (ISO 7206-4, ISO 14801, ISO 9585, ASTM F382).

What types of medical devices and healthcare products are evaluated by the IBV laboratory?

The IBV laboratory performs tests on a wide range of healthcare products, including surgical implants, exoskeletons, and assistive technologies. These evaluations assess strength, safety, durability, and functionality to ensure that each device meets the requirements of the European Regulation (EU) 2017/745 (MDR) prior to its commercialization.

What sets IBV apart from other testing laboratories in the medical industry?

In addition to its ENAC accreditation, IBV stands out for offering a comprehensive biomechanical approach that includes technical observations, critical analysis of results, and benchmarking against its proprietary databases. This added value enables the optimization of product design and safety prior to market launch.

How does IBV ensure the validity and reliability of its medical device testing?

IBV employs high-precision equipment for fatigue, bending, compression, impact, and durability testing, replicating real-use conditions. Accreditation by ENAC under the ISO/IEC 17025 standard certifies that its procedures comply with international standards, ensuring technically valid and reproducible results.

What services can manufacturers or research centers request from the IBV laboratory?

Manufacturers, regulatory bodies, and research centers can contact IBV directly to design a customized testing plan tailored to regulatory requirements and market needs. The IBV team provides support throughout the entire validation process, offering technical and biomechanical assistance to ensure product compliance.