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Partial Design Validation and changes to a critical supplier
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Partial Design Validation and changes to a critical supplier
Partial Design Validation and changes to a critical supplier
Partial Design Validation and changes to a critical supplier
Partial Design Validation and changes to a critical supplier
Partial Design Validation and changes to a critical supplier
Partial Design Validation and changes to a critical supplier
Partial Design Validation and changes to a critical supplier
Partial Design Validation and changes to a critical supplier
Partial Design Validation and changes to a critical supplier
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Some Related Topic Tags
class ii medical device, critical suppliers, design validation, design verification, design verification testing (dvt - medical devices)
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  Post Number #1  
Old 16th May 2018, 10:43 AM
Christine the QM

 
 
Total Posts: 2
Please Help! Partial Design Validation and changes to a critical supplier

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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  Post Number #2  
Old 16th May 2018, 07:34 PM
outdoorsNW

 
 
Total Posts: 28
Re: Partial Design Validation and changes to a critical supplier

Could you provide a few more details--does the LED affect safety in some way?
Is the device usable if the LED does not work?
  Post Number #3  
Old 17th May 2018, 09:10 AM
Christine the QM

 
 
Total Posts: 2
Re: Partial Design Validation and changes to a critical supplier

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.
  Post Number #4  
Old 17th May 2018, 12:56 PM
Al Rosen's Avatar
Al Rosen

 
 
Total Posts: 3,631
Re: Partial Design Validation and changes to a critical supplier

LEDs may emit light that is in a region of the spectrum that can cause retinal damage. That would be a safety concern.
  Post Number #5  
Old 17th May 2018, 07:18 PM
yodon

 
 
Total Posts: 1,095
Re: Partial Design Validation and changes to a critical supplier

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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