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