T
tobynz
Hi All
I need help in deciphering a requirement.
According to section 820.30(2), class 1 devices are subject to design controls when sub item 1 "Devices automated with computer software" is met.
We have a device that uses embedded software but no automated decisions are made by the software - all commands are initiated by the user. A legal consultant has advised that we do not need to meet the design control section of the QSR but I am unsure on the definition of ''automated with computer software'. Has anyone else run up against this definition
Edit - does this rule apply design controls to the entire device or just the development of the software within???
Cheers
I need help in deciphering a requirement.
According to section 820.30(2), class 1 devices are subject to design controls when sub item 1 "Devices automated with computer software" is met.
We have a device that uses embedded software but no automated decisions are made by the software - all commands are initiated by the user. A legal consultant has advised that we do not need to meet the design control section of the QSR but I am unsure on the definition of ''automated with computer software'. Has anyone else run up against this definition
Edit - does this rule apply design controls to the entire device or just the development of the software within???
Cheers
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