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Invitation Only

Separate Ticket or Advanced Registration Required

Repeat Solutions Circle

693 Views

Evaluation Video ViewAttendees 37

Broad Interest & Skill Building

Emerging Regulatory Trends, Pre-Marketing Submissions

Thursday, October 9, 2025

4:30 PM - 5:30 PM EST

Location/Room: 301

Session Leader(s)

Bassil Akra, PhD

CEO
AKRA TEAM, Germany

Presenter(s)

Amra Racic

Vice President - Global Government Strategy
MedTech
Tom Melvin, n.a.

Associate Professor of Medical Device Regulatory Affairs
Trinity College, Dublin
Richard G. Holborow, n.a.

Global Head of Clinical Compliance
BSI, United Kingdom

Failure to timely comply to applicable regulations can have a negative impact on various economic operators in a regulated technology sector, including but not limited to medical devices and in-vitro diagnostics. Startups and established companies working on innovative devices struggle to define a sustainable regulatory strategy addressing the expectations of management and investors. Therefore, solutions and early supportive services to help lighten the regulatory burden are highly requested. During this session, the value and importance of pre-marketing submissions will be discussed in a panel including a legislator, a notified body, and an industry representative.