Steps when changing material for class 1 medical device

Jkc3usc12

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#1
Looking for information on steps when changing material for class 1 device. Change would be on some parts going from ductile to aluminum.

Thanks
 
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chris1price

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#2
I would start with a raising a change control and following your procedures. Perform an impact analysis. Look at your dFMEA, design inputs/outputs and pFMEA to see where the material change may have an effect. Also check through the Essential Requirements and clinical evaluation. Then perform the necessary verification to ensure all requirements are met. If you have a notified body, assess whether they need to be informed.
 
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