Hello,
We are currently implementing a QMS according to ISO 13485 for our software IVD product, that we are developing in-house.
Our product is classified as a General IVD (self-certified) under the current EU IVD Directive, meaning that a Notified Body is not required for CE marking.
Internal auditing is a requirement of implementing ISO 13485. However, do we need to implement an internal auditing process before we self-certify and affix a CE mark to our product?
Thanks in advance for your help!
We are currently implementing a QMS according to ISO 13485 for our software IVD product, that we are developing in-house.
Our product is classified as a General IVD (self-certified) under the current EU IVD Directive, meaning that a Notified Body is not required for CE marking.
Internal auditing is a requirement of implementing ISO 13485. However, do we need to implement an internal auditing process before we self-certify and affix a CE mark to our product?
Thanks in advance for your help!