According to the Advocate General’s interpretation of the Directive and related soft law (i.e., MEDEV guidelines), software allowing the prescriber to detect contraindications, drug interactions and excessive doses shall qualify as a medical device.
When a software patch or device update cannot remedy a cyber threat, sometimes a recall is necessary.
The initiative also focuses on how devices will be regulated in the post-market world.
The demands of a connected device means product designers should change their approach to software development.
As software becomes more complex and connected, device manufacturers must address more risks.
Is your risk management process fully operational right now?
How companies should be identifying user needs when developing software solutions.
If exploited, unauthorized access to these devices could have dangerous consequences.
Using advanced technology still requires validation.
FDA offers help on when and what type of clinical evaluation is appropriate for SaMD.