Nancy W. Mathewson is an Associate at OFW Law. Ms. Mathewson is a member of the Medical Device Practice Group, where her practice focuses on all aspects of FDA regulation of medical devices, including in vitro diagnostics. She assists clients with a broad range of issues including, but not limited to:

• Premarket Approval Applications (PMAs)
• Premarket Notifications (510(k)s)
• Investigational Device Exemptions (IDEs)
• Quality System Regulation (QSRs)
• Medical Device Reporting (MDR)
• FDA establishment inspections
• Corrections and removals
• Medical device labeling and promotional ssues
• Establishment registration and medical device listing

Ms. Mathewson also has significant experience in the areas of ISO certification and international product registration, as well as FDA and international pharmaceutical issues.

Prior to her association with OFW Law, Ms. Mathewson had extensive industry experience in regulatory affairs and quality assurance, holding management positions in these areas in several medical device and pharmaceutical companies, including Baxter Healthcare Corporation, California Skin Research Institute, Integra LifeSciences and Ligand Pharmaceuticals.

Ms. Mathewson has significant experience in all stages of medical device product development and has worked with many device technologies, including disposable and electronic devices. Her pharmaceutical work included maintenance of regulatory submissions for existing drug products, regulatory review and input during the development of new compounds and compilation of an Electronic Common Technical Document (ECTD)

Ms. Mathewson was born in Long Beach, California and received her Bachelor of Science in Biology from Loyola Marymount University, Los Angeles, California. She received her Juris Doctor from Western State University in Fullerton, California.