R
RAlille1400
Dear all,
firstly, let me say that I really enjoy this cove as a reader. I learnt a lot of things reading post from each of you.
Here is a new issue for me (i'm really novice inrisk assessment):
drawing a risk analysis report for an unsual medical device : a disinfectant classified as class IIb. this is for a CE marking.
It's a really new discipline for me. I read ISO 14971, go through annexes... Annex C is quite useless, since i could answer 'No' to all questions.... The other annexes are just completely confusing and uninformative for me...
how shall I construct my excel sheet ? which column heads ? how quantify the risk ?
Has anyone already done the same analysis? could anyone share any template ?
I already thank every answer or comment !
all the best,
firstly, let me say that I really enjoy this cove as a reader. I learnt a lot of things reading post from each of you.
Here is a new issue for me (i'm really novice inrisk assessment):
drawing a risk analysis report for an unsual medical device : a disinfectant classified as class IIb. this is for a CE marking.
It's a really new discipline for me. I read ISO 14971, go through annexes... Annex C is quite useless, since i could answer 'No' to all questions.... The other annexes are just completely confusing and uninformative for me...
how shall I construct my excel sheet ? which column heads ? how quantify the risk ?
Has anyone already done the same analysis? could anyone share any template ?
I already thank every answer or comment !
all the best,