The Technical Training Session on Software as a Medical Device, organized by Fenin and ASD, brought together sector professionals with the aim of providing a clear and practical understanding of the regulatory framework applicable to software when functioning as a medical device. The event was designed to support companies and digital‑health developers in correctly interpreting legal and technical requirements, fostering safe, compliant, and sustainable innovation in the market.
The session included detailed technical presentations on the requirements of Regulation (EU) 2017/745 and their practical application in real‑world scenarios. A success case was also presented, offering concrete recommendations, insights, and best practices relevant to the industry. This combination of technical content and practical experience strengthened participants’ understanding of key regulatory implications.
The event also featured a space for experience‑sharing and expert dialogue, promoting a collaborative environment where participants could clarify questions and exchange technical perspectives.
Key highlights of the session:
- Enhanced understanding of the regulatory framework for medical‑device software.
- Acquisition of practical tools to support regulatory compliance.
- Strengthened technical dialogue and experience exchange among sector professionals.
The training session established itself as a key forum to support the industry in the development and certification of medical‑device software aligned with European standards.
