Re: Complaints & CAPA's for Clinical Trials
Hi, yes the product is pre-market to validate for launch.
The complexity for us is that the clinicals are outsourced to another site and they are responsible for the trials. Effectively we are sub-contracting to their site, but they do not have an ISO cert. When we gain our certification we envisage them being part of ours just for the D&D phases.
Thanks, P