Notified body quotation request

GiuliaGe

Starting to get Involved
Hello everyone,

I am asking You for advices regarding the first certification of the Quality management System as per ISO 13485 and the first MDR certification of a product.

I am wondering if it could be possible to request quotation to two different notified body prior to definitevely apply for the certification service to one of them.

Thank You for Your help.

Giulia
 

shimonv

Trusted Information Resource
Sure. Notified bodies are service providers. You can compare cost and service as much as you want but eventually you will need to chose one noticed body to go with.

Good luck,
Shimon
 

Raisin picker

Quite Involved in Discussions
NBs are required by MDR Article 50 to have the costs publicly available. There you can compare hourly rates. Then, you still don't know how many hours a NB will require for file review. Audit times are described somewhere, I think.

And you need to be aware that NBs are currently in high demand, so no need for them to accomodate a new customer.
 
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