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.
Human factors engineering and the tools companies can leverage will get way more sophisticated.
FDA issues two new draft guidances that explain when device or software changes require a 510(k) submission.
The strong demand for telemedicine services presents significant opportunities.
It’s more than a bolt-on. Here’s a smart approach to integrate medical devices into connected systems.