Using an ISO 9001 supplier for an ISO 13485 Company/CE Marking

[PattySQE]

Hello,

I work for a medical device manufacturer that uses a wire manufacturer that is certified to ISO 9001. Our company procedures do not mandate that all suppliers we use need to be certified to 13485. Does anyone know of any requirement for CE Marking that would specify what raw material / component suppliers of a medical device manufacturer need to have their Quality Systems certified to?

 

[Ronen E]

Hello,

I work for a medical device manufacturer that uses a wire manufacturer that is certified to ISO 9001. Our company procedures do not mandate that all suppliers we use need to be certified to 13485. Does anyone know of any requirement for CE Marking that would specify what raw material / component suppliers of a medical device manufacturer need to have their Quality Systems certified to?

There is none.

Cheers,
Ronen.