QUALITY

At the Instituto de Biomecánica (IBV), we work under high quality standards in our R&D and
testing activities. Through a multidisciplinary team of 170 professionals in fields such as
biomechanics, medicine, engineering, ergonomics, quality, user experience, and many others,
and with cutting-edge laboratory infrastructure and technologies, we support companies, public
administrations, and other stakeholders of the R&D ecosystem.

Multiple national and international recognitions attest to the technical excellence of our testing
laboratories. Among these, we are the unique laboratory accredited by the National
Accreditation Body (ENAC) for surgical implant testing and a certified organization under the EN
ISO 13485:2016 standard for the design of medical devices for third parties.

We also hold a license to manufacture medical devices, granted by the Spanish Agency for
Medicines and Medical Devices (AEMPS) under license number 5098-PS. Our products,
NedLumbar/IBV, NedMano/IBV, Nedcervical/IBV, NedRodilla/IBV, NedHombro/IBV,
NedCodo/IBV, NedSVE/IBV, eValanz System, NedRangos/IBV and NedAMHPlus/IBV, which are
part of our laboratories, are CE marked under the European Regulation 2017/745 on medical
devices (MDR).

TESTING LABORATORY ACCREDITED BY ENAC

ENAC is the Spanish Accreditation Body with internationally recognized agreements, that verifies
the technical competence of organizations that perform testing, calibration, and certification.

As the only laboratory accredited by ENAC for testing surgical implants 519/LE 1105, we stand
out from other laboratories. This accreditation demonstrates our technical competence and
ability to perform testing in accordance with the criteria established in the UNE-EN ISO/IEC
17025:2017 standard “General requirements for the competence of testing and calibration
laboratories,” within the scope of our accreditation.

BENEFITS OF WORKING WITH A LABORATORY ACCREDITED BY ENAC

Accreditation is the internationally established tool for facilitating the selection of a reliable
testing service provider. The benefits for companies of working with an ENAC-accredited
laboratory are multiple, including:

Trust and credibility: ENAC accreditation of the testing laboratory is a seal of guarantee that supports the quality and reliability of the test results obtained.
Regulatory compliance: ENAC accreditation is positioned as a way to demonstrate the technical
competence of a testing laboratory since, with the entry into force of the new European
Regulation 2017/745 on Medical Devices (MDR), the Notified Bodies that certify Conformity
Assessment for the CE marking of these devices are increasingly rigorous in their acceptance of
the tests and trials performed on samples to evaluate their safety and performance.
Access to new markets: ENAC accreditation facilitates the commercialization of products in regulated markets such as medical devices in the European Union and other countries that recognise this type of accreditation.
Risk reduction: By identifying potential design or manufacturing problems early, the risks associeated with the release of defective products are minimized.
Competitive differentiation: Manufacturers working with ENAC-accredited laboratories can
differentiate themselves from their competitors and position themselves as providers of safe,
high-quality products.

Contact our team

Learn how we can help you with your inquiries regarding our quality accreditations.