Fraunhofer Center for Assistive Information and Communication Solutions – AICOS
23.03.2026
FhP-AICOS has renewed its ISO 13485 certification, the internationally recognised gold standard for quality management systems in the medical device sector. This certification reflects our long-standing commitment to rigor, excellence, and quality, ensuring that every process we follow—from organisational management to software development—is thoroughly validated and continuously improved. Furthermore, this achievement reinforces our role as a reliable partner for companies navigating the complex journey of bringing health products to market, combining expertise, guidance, and regulatory know-how.
“ISO 13485 is, above all, the global gold standard for quality management systems in the medical device industry,” says Eduardo Barbosa, FhP-AICOS’ researcher responsible for the certification. “Achieving and renewing this certification demonstrates that we are able to minimise project and product risks as much as possible, reducing time-to-market for the medical devices we support. So, everybody wins: our partners, ourselves, and, most importantly, the end users.”
Holding this certification positions FhP-AICOS as a trusted reference for organisations navigating complex regulatory pathways. “By implementing ISO 13485, we have gained practical knowledge of regulatory requirements such as the EU Medical Device Regulation, risk management standards, and software lifecycle processes,” explains the researcher. “Combining this with our mission of bridging research and industry, we are in an ideal position to train and support organisations in certifying their medical devices and bringing them to market.”
Beyond compliance, ISO 13485 certification is a strategic enabler of innovation and competitiveness. Embedding quality and compliance from the outset allows our partners to innovate more rapidly and deliver safe, market-ready products worldwide. As Eduardo Barbosa highlights, “ISO 13485 opens doors for placing products on the market virtually anywhere in the world, giving our partners a distinct advantage and signaling to investors and customers that their products meet the highest standards.”
By renewing this certification, FhP-AICOS reinforces its long-term dedication to quality, continuous improvement, and supporting the success of its partners in the health and medical device sector.