Our mission is to support quality and product safety at every step of the medical device lifecycle.
We are a technical consultancy offering expertise in:
1) regulatory affairs in Europe, the USA and China;
2) quality management acc. to ISO 13485 and ISO 9001;
3) systems engineering, covering among others risk management (ISO 14971), usability engineering (IEC 62236) and verification and validation.
We support and empower medical device manufacturers by working closely with their teams during the development lifecycle. Our team of engineers masters the complexity of medical devices incorporating high-end robotics and SW solutions with artificial intelligence. Our approach relies on knowledge transfer to the teams by offering training and coaching on regulatory compliance while triggering and coordinating the efficient creation of technical documentation.
Our customers have chosen us as trustful partner because our hands-on approach during the development lifecycle has contributed to improve the quality of the technical documentation, to promote regulatory compliance and to accelerate time-to-market.