Partial Design Validation and changes to a critical supplier

C

Christine the QM

#1
We are a manufacture of a class II medical device and we changed our LED supplier for a device that treats wrinkles. Can I get away with a partial design validation to confirm the LED requirements for the specified application have been met? Or would I also need to do a partial verification?
 
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C

Christine the QM

#3
The LED does not affect safety in any way and no, the device wouldn't work as intended if the LED didn't function properly.
 

Al Rosen

Staff member
Super Moderator
#4
LEDs may emit light that is in a region of the spectrum that can cause retinal damage. That would be a safety concern.
 

yodon

Staff member
Super Moderator
#5
I agree with Al but also there's efficacy to consider. Why do you think these new LEDs operate the same as the old ones? Does the new supplier have sufficient controls to ensure each LED operates in the target range?

Also, it's a bit unclear by what you mean as a partial validation. Certainly, limited-scope efforts are allowed as long as the safety and efficacy concerns are addressed.
 
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