Medical Software

The DITTA Medical Software (MSW) Working Group contributes to the development of globally harmonised regulatory approach for software of medical devices and related IT networks and monitors development in various jurisdictions. The objective is to develop guidance which supports innovation and timely access to safe and effective medical software on a global scale.

  • Monitor the implementation of the IMDRF guidance on risk categorization of Software as a Medical Device
  • Discuss the specific characteristics and regulatory needs of Artificial Intelligence-based medical software