Software validation in Medical Equipment

indubioush

Quite Involved in Discussions
#21
"The specific approach and activities associated with software validation and revalidation shall be proportionate to the risk associated with the use of the software, including the effect on the ability of the product to conform to specifications."

You need to understand the risks associated with the software. When you understand the risks, that is when you will be able to help others understand the importance of validation.
 
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