Deborah Baker-Janis

Deborah Baker-Janis is a Senior Consultant in the medical device consulting practice at NSF. Deborah joined NSF in 2013 after working in the medical device industry for over 10 years, including in both regulatory affairs and product development. Her experience includes domestic and international regulatory strategies and submissions, design control documentation development, quality management systems and regulatory affairs procedure development and remediation, and training development and execution. Deborah has worked for a wide range of companies, from small startup organizations to Fortune 500 businesses, and supported the development and commercialization of a variety of Class II and III products, including cardiovascular devices, general and plastic surgery devices, gastroenterology devices, and general hospital devices.

Education:

Master of Science in Engineering (MSE), Oregon Health and Sciences University

Bachelor of Science in Biomedical Engineering (BSBME), University of Southern California

Areas of Expertise:

• U.S. Regulatory Strategy and Gap Assessment
• Q-Submissions to U.S. FDA
• U.S. Premarket Submissions
• Change Control and Regulatory Procedure Review and Remediation
• Design Control Training