N
NicoleinFlorida
Hello the cove,
I have question about the description on CE/ISO Certificate.
We have ISO 13485 Certified Contract Manufacturer that provide sterile medical device for use. Our consultant noticed that the ISO/CE certificate fails to specify "Sterile". When I talked with the representative of Contract Manufacturer, the lady told me that the NB audited the ISO Certificate of the Sterilizer and also products's sterilization validation report. But she was unaware that the "sterile" is required on the certificate.
I am not very familiar with the NB certificate process. And after googled for a while, I haven't get any clue about the requirement of "Sterile" for class IIb product. Is this required for the certificate if the contract manufacturer provides the sterile device for us? And how is the auditing process for the sterile?
Really appreciate it.
I have question about the description on CE/ISO Certificate.
We have ISO 13485 Certified Contract Manufacturer that provide sterile medical device for use. Our consultant noticed that the ISO/CE certificate fails to specify "Sterile". When I talked with the representative of Contract Manufacturer, the lady told me that the NB audited the ISO Certificate of the Sterilizer and also products's sterilization validation report. But she was unaware that the "sterile" is required on the certificate.
I am not very familiar with the NB certificate process. And after googled for a while, I haven't get any clue about the requirement of "Sterile" for class IIb product. Is this required for the certificate if the contract manufacturer provides the sterile device for us? And how is the auditing process for the sterile?
Really appreciate it.