MDR-ISO support software
Our goal was to develop a process
management tool that provides the greatest possible degree of freedom for medical device manufacturers to model their processes in a way that allows them to comply with MDR and ISO regulatory requirements, thereby ensuring continuous business operations from a regulatory perspective.
To achieve this, we established a partnership with FlexiTon Ltd., so we could fully support our partners in every aspect. As a result of our joint work, two flexible support software solutions were developed, specifically adapted for this sector.
Reference: Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices, as well as the requirements of EN ISO 13485:2016.
More information: http://www.flexiton.hu/language/hu/megoldasok/folyamatmenedzsment/ctmed/
