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
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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:
6) Does anyone know if IEC TR 80002-1:2009 is applicable to stand-alone software? I saw a post that seem to indicate it might only be applicable to when a software product needs to be verified at the user end (example hospital network) so I’m wondering if it would add any value in our case. I’ve bought so many standards so far for this risk management stuff I’d like to avoid another one if possible.
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:
6) Does anyone know if IEC TR 80002-1:2009 is applicable to stand-alone software? I saw a post that seem to indicate it might only be applicable to when a software product needs to be verified at the user end (example hospital network) so I’m wondering if it would add any value in our case. I’ve bought so many standards so far for this risk management stuff I’d like to avoid another one if possible.
