Our Product Experience
Regulatory Expertise
Class II and III Devices, IVDs and
Combination Products
Software as a medical device (SaMD)
Artificial Intelligence (AI)
Genomics
FDA PMA and Changes to PMAs
IDE, HUD/HDE, BLAs
PMAs, Premarket Notifications [510(k)]
RFDs, Orphan Drug Designation
Technical Dossiers
Risk management
Advertising and promotional issues
Product life cycle strategy