CSSi and Polsinelli are hosting a workshop designed for professionals in medical device development. The key take-aways from our program will underscore the importance of developing a product development roadmap based on the device’s regulatory strategy and secured by an IP fortress. In addition, we will cover investor preparedness and the approach to garner those strategic partnerships to ensure the successful commercialization of new medical technology.

Learn about the FDA’s use and evolution of its EUA regulatory pathway during the pandemic and best practices to transition your medical device from an EUA to an FDA cleared medical device to remain on the market in a post-pandemic world.

CSSi LifeSciences, in collaboration with Global Victoria, discuss how to prepare for the upcoming biotechnology conferences, AusMedTech, AusBiotech and BIO2021. Presenters review the latest FDA regulations for drugs and medical devices, discuss how to best approach US investors, and provide strategies for integrating into the biotechnology hubs in the United States. The goal of this bootcamp is to best prepare emerging biotechnology companies for successful interactions with investors, strategics, regulatory agencies and commercialization partners throughout the 2021 summer conferences.