Question regarding ECO process, specifically for Life Science products and defining form fit and function

D

duff999

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#1
#1
I am creating the ECO process for a Life Science products, and I am stumbling with the form fit or function definition and how it would apply to these products. Typically for medical device products I can define this pretty easy but struggling a bit on this one. Any help would be appreciated.
 
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William55401

William55401

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#2
#2
Instead of thinking about form, fit, and function, think about it from a Design Change perspective. Are DHF documents impacted? Inputs, Outputs, V& V, RMF? Ensuring DHF is maintained when Design is changed will better serve you IMHO. Getting your org to align on what is a design change will be helpful in the long term to ensure released products are maintained in a compliant state.
 
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