Inspected by the FDA. No deviations from applicable federal regulations (no 483 issued).
Medical Device:
We realize that Medical Device designers and manufacturers face a different set of challenges in their approach to gaining federal and state approvals of their new products or their new indications than do the BioTech/Pharma industries. Asentral, Inc. IRB has extensive experience in working with Medical Device studies and helping organizations navigate through the design of a safe research study.
We are a member of the Medical Development Group (http://www.meddevgroup.org/).
