Fraunhofer Center for Assistive Information and Communication Solutions – AICOSFraunhofer Portugal AICOS is dedicated to maintaining high-quality standards. Our certifications reflect our commitment to rigor, safety, continuous improvement, and regulatory compliance.
ISO 13485:2016
Fraunhofer Portugal AICOS is certified according to the ISO 13485:2016 standard ("Medical devices — Quality management systems — Requirements for regulatory purposes") since January 2025.
A Quality Management System (QMS) is a clearly defined set of processes and responsibilities that makes an organisation run how it's supposed to. AICOS' QMS is applicable to the design, development and supply of software elements to be integrated into software solutions, such as third-party medical devices.
Our goal is to deliver safe, evidence-backed and regulatory-compliant medical device software components to our partners and clients, enabling them to innovate faster, with a shorter time-to-market and an easier certification process.
DGERT Certification (Certified Training Provider)
Fraunhofer Portugal AICOS is certified as a training entity by DGERT since May 2022.
DGERT certification validates an organisation's capacity to design, develop, and deliver training courses that comply with strict quality, pedagogical, and operational criteria.
Our goal is to promote knowledge transfer and build high-level skills in technology and human-centered design, ensuring our trainees and institutional partners receive certified, high-impact, and industry-relevant education.