Why software design tools make excellent business sense
This article was originally published in Clinica
Regulators need to keep up to speed with the rapid developments in medical device software. The FDA has just strengthened its software guidance and the EU is also in the process of tightening software requirements in the Medical Devices Directive review. These developments make a compelling case for manufacturers to use software design tools that automatically generate much of the required regulatory documentation, including for premarket submissions argues consultant Trevor Lewis and associates.*
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