The new Challenges and Requirements for the Digital Health Industry

The Digital Health industry faces important challenges with new requirements and higher classifications introduced by the MDR and IVDR. For companies, maintaining state-of-the-art, Agile development practices while fulfilling regulatory requirements brings the need for well-defined strategies.


In an initial step, an assessment of existing methodologies and documentation, combined with IEC/EN 62304 training of the development team is almost always a necessity. Medidee fulfils this need by delivering specialized training either in-house or as part of the regular training offer.

In this post, we highlight some differences and correspondences in software development terms between Agile SW and SaMD development regulations, in order to help project teams work better together and channel their efforts in the right direction.

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Then, the software development team is encouraged to write product requirements that may require different levels of stratification. By establishing a system approach, and by structuring requirements, the team is empowered to master the inventory of constraints applicable to the considered software. The implementation of risk management methodologies also supports a compliant yet pragmatic software testing strategy. At this stage, Medidee consultants will coach the team and/or review the documentation as needed. 

Software team

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