Hi all.
A question arose today that I hope someone can answer.
We've been struggling with our NB for a remote audit for an MDD certification that has been postponed due to the pandemic, and last week they finally said yes.
However when asked they said that the audit was only for 93/42 / EEC certification, and that they could not audit to certify our ISO 13485 QMS.
So my question is this: is it possible to have a 93/42 / EEC certification (class III MD) without ISO 13485 certification?
What is your opinion?
A question arose today that I hope someone can answer.
We've been struggling with our NB for a remote audit for an MDD certification that has been postponed due to the pandemic, and last week they finally said yes.
However when asked they said that the audit was only for 93/42 / EEC certification, and that they could not audit to certify our ISO 13485 QMS.
So my question is this: is it possible to have a 93/42 / EEC certification (class III MD) without ISO 13485 certification?
What is your opinion?