As standards around interoperability emerge, now may be the time to look at the benefits of connected technologies.
How software is changing the legal landscape for medical device manufacturers.
As software becomes more complex and connected, device manufacturers must address more risks.
The agency issued a draft guidance that gives manufacturers information about design considerations and pre-market submissions.
Managing data, interoperability and cybersecurity issues were at the top of the list for industry stakeholders.
The comprehensive approach to human factors considers how a product operates alone, interoperability in larger settings, and data management.