Clinical Trials

Hello! Does anyone have any experience working with a clinical trials (CRO), wondering if in addition to GCP, ICH, did you also obtain ISO 13485, even though there isn't manufacturing? Thank you for any guidance!

2 Replies

@Kelly Munley
Is this a medical device?

@Kelly Munley None of my clinical teams or organizations for clinical trial operations have pursued training or certification for ISO 13485. ISO 14155 is more applicable.