This session builds on the foundations discussed in the first three sessions of the medical device series of UCSF-Stanford CERSI mini-courses. Upon completion of this session, students will be able to:
- Explain the role of different authorities and responsibilities with regulatory oversight of mobile health and medical technologies.
- Demonstrate knowledge of current framework for FDA’s regulatory oversight of mobile health and medical technologies.
- Explain current final, draft and anticipated relevant mobile medical technology guidance developed by FDA.
- Apply knowledge of current FDA’s regulatory thinking to identify, evaluate and critique regulatory status of simple mobile health and medical technologies.
- Formulate appropriate assessments of regulatory requirements for simple mobile health and medical technologies, using information from knowledge of FDA’s regulatory approach—both current and at the horizon
Who should attend
This mini-course will be most valuable to students and professionals who need an understanding of how to get medical devices into the US market while respecting FDA regulations. The course is geared toward entry level students who need to gain an understanding of submissions for the first time. Engineers, managers, supervisors, scientists, technicians, and other personnel involved in product development, manufacturing, quality assurance, or regulatory affairs that do not have an in-depth knowledge of medical device submissions will benefit from this course.
Dr. Zanchi is Founder and Managing Director of Medinnovo LLC, a consultancy firm established to support the entrepreneurial community of Silicon Valley, and an Adjunct Professor with Stanford University’s School of Medicine in the Biodesign Program, where she participates in the strategic planning activities of the Biodesign Leadership Group and is the Lead Director of “Biodesign for Mobile Health,” an entrepreneurial course.
Under Medinnovo, Dr. Zanchi has worked as a consultant, advisor or Board member with companies in the cardiovascular, imaging and mobile health industry, for some in acting executive positions joining the leadership teams at critical times of the company’s earliest stages. She is an advisor to student teams at Stanford University and a mentor at StartX, a startup accelerator.