Hello all,
I have some questions regarding interpretation of the requirements related to EN ISO 14971:2012 (I use ‘ISO 14971’ interchangeably below) and ISO 62304:2006. Note that I am fairly new to the Cove; I posted 1 question last year and couldn't even figure out how to find it again on the site...a bit pathetic on my part I guess
...
I have spent nearly 2 days reading through the many posts on these standards to make sure I didn't simply throw out questions that were answered already, and found it to be very informative, although I still have a couple of questions left over which I would greatly appreciate some guidance on.
First as background information, we are a North American manufacturer and our product is a stand-alone software which is considered "aids for disabled/handicapped people", per definition "2.9 medical device" Note 2 in ISO 14971:2012, and which we have classified as a Class A device under ISO 62304. We are compliant to ISO 62304 and are now in the process of implementing EN ISO 14971:2012 since we will be selling in Europe. Note that I am also familiar with the Essential Requirements in MDD 93/42, of which the relevant requirements are addressed by Annex ZA in EN ISO 14971.
My questions are as follows:
5) Regarding IFU and deviation 7 in Annex ZA, I realize that IFU is no longer an option in terms of a risk control measure, though in reading some of the posts you might be able to lump IFU as “adequate protection measure including alarms” with proper justification (but that's not the point of this question), but what’s not clear to me is if information to users must be disclosed for EVERY residual risk (which would be nuts). I have read much material on this and it’s still not clear. Could someone clarify?
I have some questions regarding interpretation of the requirements related to EN ISO 14971:2012 (I use ‘ISO 14971’ interchangeably below) and ISO 62304:2006. Note that I am fairly new to the Cove; I posted 1 question last year and couldn't even figure out how to find it again on the site...a bit pathetic on my part I guess
...I have spent nearly 2 days reading through the many posts on these standards to make sure I didn't simply throw out questions that were answered already, and found it to be very informative, although I still have a couple of questions left over which I would greatly appreciate some guidance on.
First as background information, we are a North American manufacturer and our product is a stand-alone software which is considered "aids for disabled/handicapped people", per definition "2.9 medical device" Note 2 in ISO 14971:2012, and which we have classified as a Class A device under ISO 62304. We are compliant to ISO 62304 and are now in the process of implementing EN ISO 14971:2012 since we will be selling in Europe. Note that I am also familiar with the Essential Requirements in MDD 93/42, of which the relevant requirements are addressed by Annex ZA in EN ISO 14971.
My questions are as follows:
5) Regarding IFU and deviation 7 in Annex ZA, I realize that IFU is no longer an option in terms of a risk control measure, though in reading some of the posts you might be able to lump IFU as “adequate protection measure including alarms” with proper justification (but that's not the point of this question), but what’s not clear to me is if information to users must be disclosed for EVERY residual risk (which would be nuts). I have read much material on this and it’s still not clear. Could someone clarify?
