Getting your Medical Device Through the Clinic and into Commercialization
Learn how to navigate the various US regulatory pathways for medical devices to expedite time to market and efficiently generate clinical data and publications to support rapid market adoption. We will touch on topics ranging from determining if you have a medical device or something else, the right regulatory pathway for your device class and indication, and finding qualified consultants and CROs, to identifying and working with the Key-Opinion-Leaders (KOLs) who will help you build good relationships with regulators and your target medical and patient communities.
Though the workshop focuses on the US Market, it will cover how to leverage approvals and data from other markets in the US and vice versa. We will discuss how startups can be creative and resourceful in their path towards regulatory success and also comply with the applicable regulatory requirements.
Key-takeaways:
• How to determine your product type and classification and its available regulatory pathways and clinical data requirements
• How to collect or generate clinical data for regulatory and commercialization needs
• Finding the right resources to test and submit your premarket regulatory applications
• How to identify and work with the right consultants and KOLs
This workshop will be led by Elsa Chi Abruzzo, RAC, FRAPS (CEO and President of Anuncia Medical.) Elsa is a medical device executive, entrepreneur, and a founding member of Anuncia Medical, Alcyone LifeSciences (now Alcyone Therapeutics), Arthromeda, Inc. and Cygnus Regulatory (formerly ARAC) with a 33+ year successful product development, operations, regulatory, quality, and clinical track record in med tech.
You can learn more about Elsa Chi Abruzzo via LinkedIn: https://www.linkedin.com/in/elsachiabruzzo/
Register here