Hi,
My company is a contract medical device manufacturer and currently searching for a new NB due to various reasons (we have had the same NB for 13 years). The current NB conducts separate microbiology audits and I questioned why that is. When the microbiology audit is performed they are auditing to the applicable 13485 standard and checking that we have our 14644 certification for all cleanrooms.
We manufacture in cleanrooms that are tested and certified by an outside company and do not perform any in-house sterilization. Our company's scope is "Manufacturing, inspection, packaging, and re-packaging of sterile and non-sterile medical devices." I am wondering if there is a requirement that we need to have the separate micro audit due to having "sterile" in the scope.
Thank you for any help!
My company is a contract medical device manufacturer and currently searching for a new NB due to various reasons (we have had the same NB for 13 years). The current NB conducts separate microbiology audits and I questioned why that is. When the microbiology audit is performed they are auditing to the applicable 13485 standard and checking that we have our 14644 certification for all cleanrooms.
We manufacture in cleanrooms that are tested and certified by an outside company and do not perform any in-house sterilization. Our company's scope is "Manufacturing, inspection, packaging, and re-packaging of sterile and non-sterile medical devices." I am wondering if there is a requirement that we need to have the separate micro audit due to having "sterile" in the scope.
Thank you for any help!