10 Sep Boston Biomedical Associates Executive to Speak at Opal Conference
Northborough, MA – Marybeth Gamber, executive director of the Regulatory & Quality Division of Boston Biomedical Associates (BBA), will be a featured speaker at the Opal 2nd Annual Medical Device Summit Midwest on October 9 in Minneapolis, MN.
Ms. Gamber will present the seminar, A Strategic Approach to 510(k) Submissions: Understanding the Landscape. “In this ever-changing regulatory environment, it’s important to understand the landscape to facilitate FDA interactions,” Ms. Gamber noted. “Developing the proper protocols for clinical trials at the beginning of a project, can have a significant impact on both expediting the approval process and helping to ensure it’s success,” she added.
Ms. Gamber is the Principal Consultant in the regulatory group at BBA. Prior to joining the company in 2009, she worked for more than 11 years in Regulatory Affairs for Boston Scientific Corporation, Acumen Medical, Concentric Medical and Bacchus Vascular Inc. where she formulated and executed aggressive regulatory strategies for medical devices, as well as created and maintained quality systems meeting ISO 13485 and FDA QSR requirements.