A
AaronM2102
First post, be gentle.
Also i apologize if this has already been answered in a previous post.
I am currently preparing for our MDSAP audit that encompasses ISO-13485: 2016. I am currently ISO-13485: 2003 and 21 CFR.
As the title says i am having some trouble with 7.1 of the 2016 standard.
I have already implemented risk management/assessment throughout the process individually (NCMR, design, supplier control and complaints...)
So do i already have this covered?
Or do i have to do some over arching risk mitigation? A process flow of how risk is applied?
Examples always help out if that is easier too.
Thanks for the help.
-A
Also i apologize if this has already been answered in a previous post.
I am currently preparing for our MDSAP audit that encompasses ISO-13485: 2016. I am currently ISO-13485: 2003 and 21 CFR.
As the title says i am having some trouble with 7.1 of the 2016 standard.
I have already implemented risk management/assessment throughout the process individually (NCMR, design, supplier control and complaints...)
So do i already have this covered?
Or do i have to do some over arching risk mitigation? A process flow of how risk is applied?
Examples always help out if that is easier too.
Thanks for the help.
-A