Romil Rambhia

Romil has 12 years of regulatory experience in Class III combination products (Transcatheter Mitral/Aortic Valve Replacement Systems and Drug Eluting Stents) and Class II medical devices (Alpha-1 antitrypsin test, Software validation, Endoscope defogging device, Holter recorder, etc)

Romil has an in-depth understanding of regulatory, quality and clinical requirements, and he has a history of successfully managing regulatory submissions such as Premarket approval (PMA), Investigational Device Exemption (IDE), Early Feasibility Study (EFS-IDE), Premarket Notification [510(k)], Design Dossier (CE Mark), European Directorate for the Quality of Medicines & HealthCare (EDQM) Certification, Shonin Submission (Japan), Clinical Trial Applications (Europe & Japan), Global Regulatory Submissions, Amendments, Supplements and Annual Reports.