WASHINGTON--(BUSINESS WIRE)-- Becker & Associates Consulting, Inc. is proud to announce the addition of six new expert members and affiliates to the BECKER CONSULTING team. These individuals will bring a diverse range of former FDA and industry expertise to domestic and international healthcare companies in need of regulatory and quality systems support.
•Mary Getz, PhD – Director of Quality Systems, Medical Device Practice
Dr. Getz has over 25 years of industry experience, including extensive expertise in developing quality and compliance strategies and solutions. She holds a Six Sigma Black Belt.
•Larry Schum – Principal Consultant
Mr. Schum specializes in quality systems development, compliance auditing, and in developing and implementing corrective action plans. He has over 30 years of domestic and international experience in the medical device industry. •Carrie Neuberger – Director of European Strategies
Ms. Neuberger has expertise in European clinical and regulatory strategies for obtaining CE Marks. She has particular experience with Independent Ethics Committee, technical file and design dossier filings, Notified Body negotiations, and ISO 9001 certifications.
•Merry Lee Bain – Regulatory Expert
Ms. Bain is a biomedical engineer with over 25 years of experience guiding new medical devices through the FDA premarket review process. She has played an integral role in the development of numerous devices, including orthopedic implants, tissue-based devices, and combination products.
We are also excited to welcome two members of our Expert Advisory Committee as full expert consultants on the Becker team:
•Tim Ulatowski – Compliance Expert; Regulatory Expert
Former Director, Office of Compliance, CDRH; Former Division Director, ODE
•Wally Pellerite – Compliance Expert
Former Assistant to the Director, Office of Compliance, CDRH
Becker & Associates Consulting, Inc., established in 2002, is a leading scientific and regulatory consulting firm, providing services to healthcare companies and regulatory counsel. Becker Consulting’s core expertise is the design and implementation of successful efforts to resolve, or avoid, challenges posed in the development of innovative products regulated by the U.S. Food and Drug Administration (FDA).
Contact:
Becker & Associates Consulting, Inc.
Meaghan Bailey, Managing Director
Phone: 202-822-1850
meaghan.bailey@becker-consult.com
