CardioMed Device Consultants

CardioMed Device Consultants is a US firm specializing in Class II and Class III cardiovascular devices, including implantable and interventional technologies. Its consultants develop FDA regulatory strategies, prepare and manage pre-submissions, IDE, 510(k), PMA and other submission packages, and coordinate agency meetings. CardioMed also supports clinical programs, preclinical testing strategy, quality systems, labeling and post-market reporting.