NEW WEBINAR: How to Get it Right — Legally Launching a Medical Device in the U.S.
Amin Wasserman Gurnani and Hansem Global will co-host an exclusive webinar on November 10, 2026 from 2:00-3:00 PM ET:
HOW TO GET IT RIGHT — Legally Launching a Medical Device in the U.S.
Click here to register.
THE CHALLENGE: The U.S. remains one of the most competitive and tightly regulated markets for medical devices. Even with a high-quality product, many companies face costly delays, not because of technology flaws, but because of gaps in documentation or misunderstanding of regulatory requirements. That’s why Hansem Global, a leading provider of multilingual documentation and regulatory content development, and Amin Wasserman Gurnani (AWG), a renowned U.S.-based FDA regulatory law firm, have joined forces to highlight key aspects of FDA regulatory requirements for medical devices in the U.S.
WHAT WE’LL COVER: To legally market a medical device in the U.S., foreign and domestic companies must comply with several key regulations. We will explain when, where, and how they apply, provide actionable guidance on navigating timelines, risk, and enforcement, and offer insights and strategies for minimizing regulatory scrutiny. Topics to be covered include:
- Medical Device Labeling
- Unique Device Identification
- Establishment Registration & Device Listing
- Marketing Applications
- Quality System Regulation
- Medical Device Reporting
WHO SHOULD ATTEND: This program is tailored specifically for small and mid-sized medical device companies seeking a clear, practical overview of how to comply with FDA requirements for a successful product launch in the U.S. Whether you are considering these requirements for the first time, expanding to the U.S. market, or looking to pressure-test your current strategy, this session will provide the knowledge and know-how you need to approach the market with clarity and confidence.
ABOUT THE PRESENTERS:
Brian Cho, Managing Director, PMP
Hansem Global
Brian’s work focuses on helping medical device companies prepare clear, accurate, and localization-ready documentation for the U.S. and international markets. He brings a practical perspective on how documentation quality, localization, and regulatory requirements align during global product launches.
Neil O’Flaherty, Partner
Amin Wasserman Gurnani
Neil is a seasoned veteran with over 36 years of legal experience representing medical device companies and assisting clients with Class I, II, and III medical devices at any stage in their product’s premarket or commercial lifecycle. Companies, from multinational firms to start-ups, look to Neil for his deep substantive knowledge of complex FDA requirements and policies, and his ability to help them succeed in a highly regulated industry.
SECURE YOUR SPOT TODAY!
Click here to REGISTER NOW
If you have any questions, please contact:
