In a constantly growing global medical device market, marked by increasingly strict regulation and rising demands in patient safety, the certification and validation of medical devices has become a critical requirement for market access. The need to demonstrate the biocompatibility of materials, minimize risks, and guarantee product reliability throughout their entire life cycle positions accredited biomedical testing as a key element for the sector’s competitiveness.
Image Credit: AIMPLAS
In this context, AIMPLAS, the Plastics Technology Centre, has taken another step forward in the field of health and consumer safety after obtaining a new accreditation from the National Accreditation Body (ENAC) to perform in vitro cytotoxicity testing on medical devices according to the UNE-EN ISO 10993-5 standard. This accreditation adds to all those already held by AIMPLAS laboratories in key areas for consumer safety and sustainability, such as testing for food contact materials and the evaluation of plastic recycling and recyclability, reinforcing its positioning as a reference center in the technical validation of materials and products.
In this case, the new accreditation obtained under the demanding UNE-EN ISO/IEC 17025:2017 standard on May 8th, certifies the technical competence of the center and the reliability of its results. Thanks to this, AIMPLAS positions itself as a strategic partner for the healthcare industry.
A Boost for Medical Device Safety
The in vitro cytotoxicity test constitutes one of the fundamental pillars in the biological evaluation of materials, allowing the detection of potential adverse effects on cells before products reach the market. With this newly accredited capability, AIMPLAS offers companies an essential tool to accelerate the development of safe medical devices, reduce risks, and comply with national and international regulatory requirements.
Furthermore, the ENAC accreditation brings a differential value to the tests carried out by AIMPLAS, as it guarantees their official recognition and facilitates the acceptance of results in global markets. This allows companies in the healthcare sector to streamline their certification processes, reduce development times, and increase the confidence of both clients and regulatory authorities.
Obtaining this accreditation is part of the center’s firm commitment to technical excellence, innovation, and knowledge transfer–key pillars for driving a safer, more sustainable, and competitive industry. With it, AIMPLAS reinforces its positioning in the fields of health, consumer safety, and advanced materials, expanding its service portfolio in one of the most demanding and strategic sectors.