We use cookies to deliver our online services. Details of the cookies we use and instructions on how to disable them are set out in our Cookies Policy. By using this website you agree to our use of cookies. To close this message click close.

Patricia B. Shrader

Senior Counsel
Washington, D.C.

Patricia B. Shrader

Pat Shrader brings invaluable knowledge to her clients through her decades of service in the medical device industry and expansive experience in U.S. medical device law, as well as her understanding of global regulatory requirements for devices.

She is well-known in the medical device industry and has proven leadership in Fortune 500 companies. Pat developed the global regulatory strategy for two well-known medical technology companies. She also assisted in the development of the first policy and procedure manual, to meet the then-newly implemented Good Manufacturing Practices (GMP) regulations for medical devices. She has appeared before congressional committees including a House subcommittee to urge Congress to improve medical device manufacturing inspections.

Pat first began with the firm as a clerk in the FDA practice while in law school. She has assisted hundreds of medical device companies of all sizes with pre-market strategies and submissions and post-market activities, including Quality Systems and compliance issues.

Prior to re-joining Hogan Lovells, Pat was the Senior Vice President of Regulatory and External Affairs at Becton Dickinson, and then Vice President of Regulatory Affairs at Medtronic, the world's largest standalone medical device company. She is also a founder of the In Vitro Diagnostics Roundtable, an FDA and industry forum, one of the longest standing industry activities in the medical device arena.

In addition to her accomplishments in global regulatory work, Pat received the Citizenship Award from Ramapo College and was an Executive Women of New Jersey Salute to Policy Makers 2010 honoree. She was presented the FDA Group Recognition Award for the IVD Roundtable and Certificate of Appreciation for outstanding contributions made during the CDRH-wide organization transformation effort. Pat has also received an AdvaMed award for passage of H.R. 5651, the Medical Device User Fee and Modernization Act, 2002.

Areas of focus

Education and admissions

Education

  • J.D., Georgetown University Law Center, 1988
  • M.A., Hood College, 1987
  • B.A., McDaniel College, 1972

Bar admissions and qualifications

  • District of Columbia
  • Maryland

Latest thinking and events

View More
Loading data