We assist clients in preparing all types of premarket submissions, including investigational device exemptions (IDEs), presubmissions, 510(k) notices, de novo submissions, premarket approval applications (PMAs), and related submissions. We are involved in a substantial portion of all PMA applications filed annually with FDA, as well as dozens of presubmissions and IDE submissions and hundreds of 510(k) notices each year. We also assist our clients with preparation and submission of Technical Files or Design...