How many hours for a NB to review Technical Documentation?

#1
Hi everyone,

My head is wrecked. I am trying to do a budget. I have the Notified Body's hourly cost. But I have absolutely no idea how many hours it would take them per Device class.

It doesn't even have to be precise. Just a ballpark!

I am hoping someone could help?

Thank you!
 
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Sidney Vianna

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Staff member
Admin
#2
Wouldn't that depend on the complexity of the device? You could also be in for a surprise if you think NB's quote all jobs based on an hourly rate; as we have a seller's market, chances are, they might be quoting lump sum fees.
 
#3
Hi!

here in my work, the evaluation takes approximately 6 months we have class IIb (non-active) class IIa and class I products.
we are dental medical products company (dental implants)
 

yodon

Staff member
Super Moderator
#4
As @Sidney Vianna mentioned, you'll likely not get a straight-hourly rate for the initial review. You could get a quote from them! I do believe, though, that if they have issues and require additional time, they will tack on the effort based on an hourly or daily rate. Several years ago, the NB I used billed out at > $3500 / day or > $450 / hr. I would bet those have increased.
 
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