New Medical Devices Software (MDSW) should be developed in Europe in accordance with the requirements of the new legislative framework given by REGULATION (EU) 2017/745 on medical devices (hereinafter MDR), which will be applicable from the 26th of May, 2021.
Asphalion’s Medical Devices Experts have developed a white paper which provides an overview of the special challenges that MDSW developers will face under the MDR.
This document is the first of a series that aims to provide guidance for any stakeholder involved in MDSW development, including engineers, regulatory affairs professionals and entrepreneurs, and other professionals that might have in sight to bring into the European Economic Area (EEA) market new software that constitutes a medical device (MD) on its own.
In the coming issues of the series the following topics will be addressed:
- MDSW life cycle process according to IEC 62304.
- MDSW Cybersecurity and Safety Risk Management.
- Artificial Intelligence-based MDSW development.
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