Each year, we are involved in drafting and submitting hundreds of 510(k) notices, a substantial portion of all PMA applications filed with FDA, and a multitude of presubmissions, humanitarian device exemptions, De Novo requests, and IDE submissions. We assist companies in preparing for make-or-break Advisory Panel meetings. We can guide you through the conformity assessment procedure for the CE marking of your device and assist you in interactions with your notified body. Following clearance or approval, we can provide guidance on the reporting and notification requirements for your proposed design, manufacturing, and labeling modifications.
