Greenleaf’s Medical Device and Combination Products Team guides clients through the complete regulatory process, from the earliest stages of product development, through the FDA review process, to marketing authorization and compliance with postmarket requirements and quality systems. Greenleaf applies extensive regulatory expertise to determine the best regulatory approach for a product and develop a comprehensive strategy to achieve a successful result. 

Additionally, Greenleaf’s deep bench of FDA experts advises litigators representing FDA-regulated clients and provides authoritative, objective expert opinions in disputes involving regulatory issues, including complex commercial litigation, unfair competition and false advertising cases, intellectual property litigation, product liability class actions, and securities class actions.

Experts from Greenleaf’s Medical Device and Combination Products Team also provide advisory services that include extensive research and due diligence for investors engaged in potential deals that require regulatory risk analyses before and after decisions and transactions.

Learn more about Greenleafs Medical Devices & Combination Products Services:

Download Medical Devices & Combination Products Info Sheet

Download Medical Devices & Combination Products Capabilities Deck