Module 18 - Drug Device Combinations and Other Technologies

30/11/2023

Software as a medical device

If the software is part of a hardware medical device • It does not meet with definition of Software as a Medical Device

Software as a medical device… • Must have a medical purpose in its own right.

The Organisation for Professionals in Regulatory Affairs

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Guidance on Software as a Medical device

The Organisation for Professionals in Regulatory Affairs

12

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