In this video I’m going to briefly answer the following question:
“Is the ISO14155 applicable to the post-market stage of your clinical trial?”
Transcript:
In today’s video I’m going to briefly answer the following question:
“Is the ISO14155 applicable to the post-market stage of your clinical trial?”
In the latest 2020 version, Annex I brings welcome clarifications on the applicability of the requirements of this standard to the different clinical development stages.
It also includes a useful table for the planning and design of clinical investigation in all phases of the medical device lifecycle.
Annex I clearly emphasize on the fact that the ISO14155 is applicable to all clinical development stages, but also clearly points out which exemptions can be made when getting into the post-market stage and asks for a clear justification to be given for each exemption.
So yes, the ISO14155 is applicable to the clinical post-market stage whether or not with some possible exemptions.
Would you like to know which exemptions are allowed for the post-market stage, get yourself a copy of the standard or trained on it.
