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:
- Defining the Intended Use of medical software to ensure proper deployment and adherence to regulations.
- Identifying Associated Risks with medical software, highlighting the importance of thorough risk management.
- Describing Software Functionalities clearly and effectively for stakeholders.
- 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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