TECNALIA achieves GLP Certification for Medical Device Biocompatibility to Strengthen the Development and Certification of Medical Devices
Accreditation for Good Laboratory Practice (GLP) in medical device biocompatibility studies enables TECNALIA to provide manufacturers and developers with greater regulatory assurance, reinforcing the quality and traceability of the data required under the European Medical Device Regulation (MDR).
TECNALIA, a leading centre for applied research and technological development, has obtained Good Laboratory Practice (GLP) Compliance Certification to conduct biocompatibility studies on medical devices in accordance with ISO 10993, marking an important milestone that further strengthens its ability to support companies in the biomedical sector within an increasingly demanding regulatory environment.
The entry into force of Regulation (EU) 2017/745 on medical devices (MDR) has significantly increased the requirements related to the preclinical and clinical evidence necessary for the certification and marketing of medical devices. In this context, the quality, reliability, and traceability of the data generated during product development are key aspects for advancing through regulatory processes with confidence.
Tests conducted in accordance with Good Laboratory Practice offer significant advantages for manufacturers and developers. Among these are higher-quality results and improved traceability, which facilitate evaluation by notified bodies, as well as a more robust interpretation of the technical documentation required for certification. Furthermore, they enable better alignment with current regulatory requirements, helping to minimize observations, additional requirements, and potential delays in bringing products to market.
This certification is the result of the experience accumulated by TECNALIA’s Health Biomaterials team in the field of biological evaluation of medical devices and biomaterials. The incorporation of the GLP framework reinforces confidence in the results generated, reduces regulatory risk, and ensures compliance with the required quality standards at every stage of the process.
TECNALIA also offers non-GLP evaluations for early-stage development, material screening, and prototyping activities, where speed and cost-efficiency are often prioritized over formal certification requirements.This option allows manufacturers to optimize their timelines and budgets based on the development stage of their products.
With this achievement, TECNALIA further strengthens its position as a trusted technology partner for companies seeking to accelerate the development, validation, and certification of medical devices with greater regulatory confidence.