Christine the QM

Quality Systems Manage
#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?
 

Al Rosen

Super Moderator
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

Forum Moderator
Staff member
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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