QUALITY

At the Institute of Biomechanics (IBV), we adhere to high quality standards in carrying out our R&D&I and testing activities. Through a multidisciplinary team of 170 professionals in fields such as biomechanics, medicine, engineering, ergonomics, and quality, user experience, among many others, and with state-of-the-art laboratory infrastructure and technologies, we support companies, public administrations, and other stakeholders in the R&D&I ecosystem.

Numerous national and international recognitions attest to the technical excellence of our testing laboratories, including the fact that we are the only laboratory accredited by the National Accreditation Body (ENAC) for testing surgical implants and a center certified to 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 Health Products (AEMPS) under license number 5098-PS. Our products NedLumbar/IBV, NedMano/IBV, NedCervical/IBV, NedKnee/IBV, NedShoulder/IBV, NedElbow/IBV, NedSVE/IBV, eValanz System, NedRangos/IBV, and NedAMHPlus/IBV—which are developed in our laboratories—bear the CE mark in accordance with European Regulation 2017/745 on medical devices (MDR).

TESTING LABORATORY ACCREDITED BY ENAC

The National Accreditation Body (ENAC) is the Spanish agency—which has international recognition agreements—that verifies the technical competence of organizations that perform testing, calibration, and certification.

As the only ENAC-accredited laboratory for testing surgical implants (519/LE 1105), we stand out from other laboratories, and this accreditation demonstrates our technical competence and ability to conduct 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 AN ENAC-ACCREDITED LABORATORY

Accreditation is the internationally recognized tool used to facilitate the selection of a reliable testing service provider. There are many benefits for companies that work with an ENAC-accredited laboratory, including:

Trust and credibility: ENAC accreditation of the testing laboratory is a seal of quality that guarantees the quality and reliability of the test results.
Regulatory Compliance: ENAC accreditation serves as a means of demonstrating a testing laboratory’s technical competence. With the entry into force of the European Medical Device Regulation (MDR) 2017/745, Notified Bodies are becoming increasingly rigorous in their acceptance of tests performed on samples to evaluate the safety and performance of products.
Access to new markets: ENAC accreditation facilitates the marketing of products in regulated markets, such as the market for health products and medical devices in the European Union and other countries that recognize this type of accreditation.
Risk reduction: By identifying potential design or manufacturing issues at an early stage, the risks associated with placing defective products on the market are minimized.
Competitive differentiation: Manufacturers that work with ENAC-accredited laboratories can set themselves apart from their competitors and position themselves as suppliers of safe, high-quality products.

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Find out how we can help you with your questions about our quality certifications.