NEWS | IMDRF Releases New Guidance on Medical Device Software

January 30, 2025

Just yesterday, the International Medical Device Regulators Forum (IMDRF) published a new guidance document titled “IMDRF DOCUMENT ON SOFTWARE AS MEDICAL DEVICE: Characterization Considerations for Medical Device Software and Software – Specific Risk”. The document, created by the IMDRF Software as a Medical Device Working Group, provides key insights and recommendations for:

  1. Defining the Intended Use of medical software to ensure proper deployment and adherence to regulations.
  2. Identifying Associated Risks with medical software, highlighting the importance of thorough risk management.
  3. Describing Software Functionalities clearly and effectively for stakeholders.
  4. Integrating AI-Based Functionalities for medical purposes, addressing specific challenges related to AI.

 

The annexes also include practical examples to illustrate the application of these guidelines, making this document a helpful resource for anyone involved in medical device software development and regulation.

You can have a look at the complete guide here: IMDRF New Guidance on Medical Device Software

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