Agile Methodology for Medical Devices
The Agile methodology offers medical device developers options that anticipate and prevent the bottlenecking and potential crisis points to which static development models are normally vulnerable.
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The Agile methodology offers medical device developers options that anticipate and prevent the bottlenecking and potential crisis points to which static development models are normally vulnerable.
You’ll gain more confidence that your recently-released products avoid recalls, fines, or worse if you perform failure mode and effects analysis (FMEA) as part of your risk management.
Poorly-written requirements can cause a lot of problems in software development, and sometimes the symptoms can be traced back to requirements gathering.
Devices recalled nationwide are typically taken to task for usability issues that could have been prevented with proper usability testing throughout a product’s development lifecycle.
Frost & Sullivan recently released a report on the challenges regulated industries face and how modern requirements management can help.
No one sets out to create a product that’s an abject failure, which is one of the reasons Failure Mode and Effects Analysis (FMEA) exists.
Skipping the requirements doc really isn’t a viable approach. How, then, can you create a good product requirements document with minimal hassle?
What better reference point for collaborative engineering than the most famous songwriting duo of all time: The Beatles’ John Lennon and Paul McCartney.
While connected medical devices provide opportunities for instantaneous results and early intervention, they’re also more vulnerable to cyberattacks.
Developers often want to freeze software requirements following some initial work and then proceed with development, unencumbered by those pesky changes. This is the classic waterfall paradigm. It doesn’t work well in most situations.