N
noedum
Good morning,
We are a french company and we are ISO 13485, ISO 9001 certified for design, manufacturing, sales and servicing support for neuro muscular electro stimulator. Today we market only one product which is a class IIa medical device (according European directive).
We would like to start business with Brazilian company for distribution of the product. In order to get ahead of the registration, we are looking for a registrar/certification body which could issue a ISO 13485 or 9001 certificate recognized or accepted by ANVISA. It could allow us reduce the delay of registration. In fact, our notified body is not accredited for Brazil but it ask for the list of certification bodies recognized in Brazil. I searched on ANVISA website, INMETRO or certification bodies website but its difficult to find it. Does somebody know European certification bodies which can make such service (Except TUV)?
Thanks in advance for helping,
BR
We are a french company and we are ISO 13485, ISO 9001 certified for design, manufacturing, sales and servicing support for neuro muscular electro stimulator. Today we market only one product which is a class IIa medical device (according European directive).
We would like to start business with Brazilian company for distribution of the product. In order to get ahead of the registration, we are looking for a registrar/certification body which could issue a ISO 13485 or 9001 certificate recognized or accepted by ANVISA. It could allow us reduce the delay of registration. In fact, our notified body is not accredited for Brazil but it ask for the list of certification bodies recognized in Brazil. I searched on ANVISA website, INMETRO or certification bodies website but its difficult to find it. Does somebody know European certification bodies which can make such service (Except TUV)?
Thanks in advance for helping,
BR