ISO 14155 GAP analysis

P

pousse

#1
I have a Corrective Action from a NB Technical File review that has me pretty stumped.
The trial was conducted in 2007 but the results of PMS or PMCF processes does not included and the manufacturer claim the trial was conducted according to EN ISO 14155:2011 but GAP analysis or justification did not provide.

Extensive Googling hasn't helped much up to know. The clinical trial was done according to to 2003 version of the standard, and in the meanwhile (long while ago), a new version was released. Does this mean that we need to do a GAP analysis between the old and the latest version of the standard itself, and prove compliance to the new standard?

Also not sure how the clinical trial would in itself include PMS and PMCF, as it'sc conducted pre-market.

Anyone had anything like this before?

Thanks.
 
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FoGia

Involved In Discussions
#2
The last version of the harmonized standards are expected to be applied unless you have a rationale for not doing so (hence the role of the gap analysis). This principle is applicable for all harmonised standards (and not only 14155).
Regarding the PMS/PMCF question, maybe that the NB in your case could not rely on PMS data to replace the data collected during your pre-market rial and so wants you to update the content of that trial data.

But considering the grammatical errors of the sentence you quote it may not be a bad idea to ask for clarification.
 
P

pousse

#3
Thanks so much your reply. I am working on a checklist type document to try and meet the gap analysis request.

Still not sure how I would "update" or change in any way the clinical investigation data, as that seems to be something that is done and dusted. I'm going to try gather more PMS data, and create a PMS report based on that.

There shouldn't be any need to redo clinical investigation. This is a software product used as part of a diagnostic x-ray system, we thought to group two software products together and cut down on the certification/RA requirements...it's going great as you can see...:bonk:
 

FoGia

Involved In Discussions
#4
You won't change the data, but you may need to provide more information on the way the study was conduceted. Btw, if your PMS report wouldn't be sufficient you can plan to redo the exercise in the next couple of years since 14155 is to be updated soon.

Good luck!
 
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