H
Hi everybody !
I have just sent my new MD to be certified following the IEC60601-1 3rd edition.
I joint to the different files all the development process of the software according to IEC62304.
The answer of my NB was that it was not able to include the IEC62304 (neither clause 14 of general standard).
My questions are then: is this a problem for my CE marking? And, which NB is able to certify compliance with IEC6230?
Thanks a lot for your answers.
Houarcheneger.
I have just sent my new MD to be certified following the IEC60601-1 3rd edition.
I joint to the different files all the development process of the software according to IEC62304.
The answer of my NB was that it was not able to include the IEC62304 (neither clause 14 of general standard).
My questions are then: is this a problem for my CE marking? And, which NB is able to certify compliance with IEC6230?
Thanks a lot for your answers.
Houarcheneger.
