Topic: Time to rethink developing software-intensive medical devices
Understanding medical device software compliance starts with processes
Accelerated change management with The Hub
Managing product data in a platform (The Hub) enabled the product team to rapidly respond to unexpected design changes at the worst time (in the middle of V&V) while still generating rigorously controlled documentation (using documentation automation).
Want to succeed with complex medical devices?
Companies that embrace these proven methods for handling their unique challenges dramatically increase the odds of success.
Understanding the Software Landscape
At a medical device company there are many types of software that need to be validated and the rules and requirements are different for each type. This diagram of the “software landscape” is intended to help people understand what type of software they’re working with.
Upcoming Events
Bay Area Biomedical Device Conference
April 2, 2025 San JoseState
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