We have extensive hands-on experience managing the
regulatory process in partnership with the U.S. FDA, European Notified Bodies and Competent Authorities / Ministries of Health, Canadian Department of Health and Japanese in-country care-takers.
Initial strategy
Predicate identification
Indications for Use negotiation
IDE, PMA, 510(k) submission preparation
513(g) requests for product classification
FDA negotiation
Agency request for additional information
Clearance / Approval
