Hello,
I'm shopping around for a notified body for our Class I (annex 9) stand-alone software. I was just told by the NB I just spoke to that they would need to perform an initial audit and then put us on an annual schedule for ISO 13485 certification.
My understanding (which may be wrong) is that for a Class I device, you only need to self-certify with a NB (ie no scheduled audits, no 3rd party certification required). Is this correct? Are maybe some NBs different than others in what THEY need for you to be their "client"?
Any insight on this would be appreciated. I don't fear an audit.. it's just not what I expected. Thanks!
I'm shopping around for a notified body for our Class I (annex 9) stand-alone software. I was just told by the NB I just spoke to that they would need to perform an initial audit and then put us on an annual schedule for ISO 13485 certification.
My understanding (which may be wrong) is that for a Class I device, you only need to self-certify with a NB (ie no scheduled audits, no 3rd party certification required). Is this correct? Are maybe some NBs different than others in what THEY need for you to be their "client"?
Any insight on this would be appreciated. I don't fear an audit.. it's just not what I expected. Thanks!