Given the popularity of medical apps and software being used within the framework of Medical Devices and IVDs, their importance is rising annually. Along with this one may find the challenge of finding the border between software intended for wellbeing or fitness purposes and software designed for medical purposes according to MDR/IVDR.
We support you in qualifying and classifying your software by considering guidelines such as the “MDCG 2019-11 Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR”. Regardless of whether you use agile, V-model or waterfall methods we will ensure your Medical Device Software complies with the requirements outlined in the Harmonised Standards IEC 62304 and the Health Software Validation Standard IEC 82304.
