With over 25 years of medical device regulatory affairs
experience in product registrations, regulatory compliance, legal
representation and research, our Principal Regulatory Counsel, Annette M. Zinn,
M.P.H., Ph.D., J.D., has the qualifications and experience to help you attain
success.As a member of our team, she
provides regulatory and legal assistance to the public and private sectors for
innovative medical device technologies.
Dr. Zinn holds a Ph.D. in Management & Policy from the University of Texas,
School of Public Health, a J.D. from the South
Texas College of Law, and a M.P.H. from The University of Texas School of
Public Health.She is a member of the
American Bar Association (Section: Administrative Law), the Texas Bar
Association(Sections: Administrative
Law; Health Law), the United States District Court, Southern District of Texas,
the Food and Drug Law Institute, Regulatory Affairs Professional Society and
the American Public Health Association.In addition to her education and associations, Dr. Zinn has published
and presented on topics including medical device advertising, quality,
regulation and law.
Dr. Zinn has extensive experience interacting with FDA
regarding a wide range of activities.As
regulatory counsel for cardiac rhythm management and neuromodulation companies,
she has developed strategies for regulatory submissions worldwide including
clinical trials and marketing approvals.She has implemented these strategies and prepared regulatory submissions
for FDA (two panel meetings) and other regulatory agencies to obtain marketing
approvals for new indications (PMA), design changes, manufacturing changes,
annual reports and post-approval studies. Dr. Zinn has been involved in many different
aspects of FDA regulation including interfacing with reviewers to satisfy
requirements, participated in FDA advisory panel meetings, assisting FDA with
facility inspections, handling complaints from health care providers and
patients, and conducting internal audits to ensure compliance with law and
regulations.
As an attorney, Dr. Zinn understands the laws and policies
associated with the regulation of medical devices.She is competent and capable of handling
legal activities including review of contracts, warranty and product liability
claims, copyright and trademark filings and patent extension requests.Her legal skills allow her to be efficient
and effective at researching regulatory, legal and business issues and advising
your company of appropriate legal actions.In addition, she has assisted in compliance related activities including
handling product complaints, internal audits, and facility inspections.
As an international regulatory advisor, Dr. Zinn has
provided services to her clients designing and preparing regulatory submissions
for marketing approvals and new product designs.She has provided legal and regulatory
services to medical product manufacturers concerning strategic planning,
product registrations, quality system registrations, FDA export clearances and
distributor contracts.
In addition to Dr. Zinn’s corporate experience, she has
served as an adjunct faculty member at the University of Houston
College Of Law where she was a co-instructor for
the Food & Drug Law Course in the Master of Laws, LLM, program.
We are proud to offer medical device regulatory affairs
services under the guidance of Dr. Zinn.Her legal and scientific acumen allow us to provide outstanding
consulting services to the medical device community both in the United States
and abroad.
Regulatory Services:
Developing
and implementing strategies for regulatory submissions
