FDA vs. EU Regulatory Pathways: Factors Every Startup Must Consider with Go-to-Market Strategy

Obtaining regulatory market clearance and/or approval is a significant milestone for any medical device company, especially startups.

Navigating the various regulatory submission types and pathways from numerous global regulatory bodies can be a challenging pursuit for teams entering a new market for the first time.

Should a startup choose the European market first? Or is it more straightforward to pursue FDA for the US market to start? What are the deciding factors startups must consider when choosing between different markets to pursue?

Join the esteemed regulatory experts from the Greenlight Guru Regulatory Advisory Board for a lively panel discussion where we will compare and contrast FDA versus EU regulatory pathways (along with other sought after markets), discuss relative timelines and costs as well as the importance of clinical data, and other relevant topics.

Specifically this webinar will cover:

• Similarities and differences between regulatory pathways in US vs EU markets, and others
• FDA pre-submission process
• EU requirements for clinical data
• Startups and/or companies new to medical device industry (i.e. EUA)
• Go-to-market timeline constraints
• Notified bodies: non-responsive or ambiguous
• FDA clearance / approval becoming gateway for other markets

Who should attend?

• Medical Device Executives
• Regulatory Affairs Professionals and Management
• Quality Professionals and Management
• R&D Engineers and Management