Even the most affordable, desperately needed software will have to prove itself to decision-makers and fellow employees — not just once, but many times.
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.
In the rush to build a product, it’s important to establish boundaries for each team while also working as a unit, and develop processes to head off trouble before it begins.
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.