Complaints & CAPA's (Corrective Action Preventive Action) for Clinical Trials

When there is a complaint on your medical device product during clinical trials (and subsequent CAPA), does this information need to be captured in your Management reviews with respect to ISO13485? and is this something the notified body would expect to see captured? Thanks, P

Re: Complaints & CAPA's for Clinical Trials

PPcricket said:

When there is a complaint on your medical device product during clinical trials (and subsequent CAPA), does this information need to be captured in your Management reviews with respect to ISO13485? and is this something the notified body would expect to see captured? Thanks, P

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Depending on your systems, it might not fall under "Complaints Handling" per se, but if not it would certainly fall under Design Control / Design Validation.

Either way, I would definitely expect to see it captured.

As for coverage in Management Review, it depends on your systems, and the nature of the feedback.

Re: Complaints & CAPA's for Clinical Trials

Hi
what would be for you a complaint during a clinical trial ? Are you refereing to an event that could present a vigilance issue?
And which kind of trial :
- a pre marketing trial to validate the Device , in this case your complaint is processed according to you Design control process
-or a post-marketing trial ?

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

Re: Complaints & CAPA's for Clinical Trials

They don't need to be ISO certified per se; but you will need to show that they are competent to do their job (i.e. that they meet ISO14155 and anything expect from a CRO).

Their ability to handle adverse incidents, including liaising with you (the sponsoring organization) about complaints, is critical.