"We provide high quality and flexible yet affordable medical device solutions for manufacturers."
In 2016, CEMDS Ltd. was established to provide a complete service platform for medical device and in vitro diagnostic device manufacturers, from designation to certification, and support them throughout their product’s life cycle in the market.
Our Case studies
Class I devices
Class I devices As the COVID pandemic became global, many businesses in Hungary wanted to participate in the defense, including manufacturers who have not…
Class IIa devices
Class IIa devices A Class IIa device requires the involvement of a Notified Body (NB) in its conformity assessment procedure to determine whether the…
High risk devices
High risk devices Thanks to the MDR, many devices in higher risk categories are controlled much more rigorously than before. Implantable devices cannot be…
Software and electrical equipment
Software and electrical equipment Medical devices are becoming increasingly common in our daily lives; while a few decades ago not even the existence of a home…
Custom-made devices
Custom-made devices Many small and medium-sized businesses produce custom-made medical devices that are manufactured to order, adapted to the patient’s…
IVD devices
IVD devices For in vitro diagnostic devices REGULATION (EC) No 2017/746 (IVDR) will be applied during & after the IVDD/IVDR transition, but deadlines are…
Biological Evaluation
Biological Evaluation of an Implantable Medical Device According to EN ISO 10993-1 In this case study, we examine the biological evaluation of an implantable…
AI-Powered Medical Device Software
AI-Powered Medical Device Software: A Novel Development In this semi-fictious case report, we present a novel AI-powered medical device software developed by a…