AI-Powered Medical Device Software

AI-Powered Medical Device Software: A Novel Development In this semi-fictious…


Biological Evaluation

Biological Evaluation of an Implantable Medical Device According to EN ISO…


PMS, PMCF

Post-Market Surveillance (PMS) and Post-Market Clinical Follow-Up (PMCF) for a…


IVD devices

IVD devices For in vitro diagnostic devices REGULATION (EC) No 2017/746 (IVDR)…


Custom-made devices

Custom-made devices Many small and medium-sized businesses produce custom-made…


Software and electrical equipment

Software and electrical equipment Medical devices are becoming increasingly…


High risk devices

High risk devices Thanks to the MDR, many devices in higher risk categories are…


Class IIa devices

Class IIa devices A Class IIa device requires the involvement of a Notified…


Class I devices

Class I devices As the COVID pandemic became global, many businesses in Hungary…