P
pousse
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.
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.