About

BILL KURANI, M.S.R.A., M.S.E.E., is head and director of regulatory affairs and quality assurance at a Silicon Valley-based global genomics company. He has over 20 years of experience in regulatory affairs and quality assurance and has implemented successful product design, development, verification, validation and manufacturing process programs for medical device companies. Kurani has held leadership positions at several leading organizations—Natera, Affymetrix, Ligand Pharmaceuticals, Kaiser Permanente, and Abbot Diagnostics—and secured regulatory and marketing approvals for medical devices and drugs from the FDA, the EU, and other global regulatory agencies.

Bharat (Bill) Kurani's courses currently open for enrollment

Foundations in Medical Devices: Developing Premarket U.S. Regulatory Strategies and Working in a Regulated Environment

REGL.X410
$795
  • Flexible Attend in person or via Zoom at scheduled times.
Schedule
Date
Start Time
End Time
Meeting Type
Location
Thu, 02-26-2026
6:00pm
9:00pm
Flexible
SANTA CLARA / REMOTE
Thu, 02-26-2026
6:00pm
9:00pm
Flexible
SANTA CLARA / REMOTE
Thu, 03-05-2026
6:00pm
9:00pm
Flexible
SANTA CLARA / REMOTE
Thu, 03-05-2026
6:00pm
9:00pm
Flexible
SANTA CLARA / REMOTE
Thu, 03-12-2026
6:00pm
9:00pm
Flexible
SANTA CLARA / REMOTE
Thu, 03-12-2026
6:00pm
9:00pm
Flexible
SANTA CLARA / REMOTE
Thu, 03-19-2026
6:00pm
9:00pm
Flexible
SANTA CLARA / REMOTE
Thu, 03-19-2026
6:00pm
9:00pm
Flexible
SANTA CLARA / REMOTE
Thu, 03-26-2026
6:00pm
9:00pm
Flexible
SANTA CLARA / REMOTE
Thu, 03-26-2026
6:00pm
9:00pm
Flexible
SANTA CLARA / REMOTE
Thu, 04-02-2026
6:00pm
9:00pm
Flexible
SANTA CLARA / REMOTE
Thu, 04-02-2026
6:00pm
9:00pm
Flexible
SANTA CLARA / REMOTE
Thu, 04-09-2026
6:00pm
9:00pm
Flexible
SANTA CLARA / REMOTE
Thu, 04-09-2026
6:00pm
9:00pm
Flexible
SANTA CLARA / REMOTE
 

This class is offered in an online synchronous format. Students are expected to log into this course via Canvas at the start time of scheduled meetings and participate via Zoom, for the duration of each scheduled class meeting.

To see all meeting dates, click "Full Schedule" below.

You will be granted access in Canvas to your course site and course materials approximately 24 hours prior to the published start date of the course.

Recommended Text:
Fundamentals of Medical Device Regulations, 5th Ed., RAPS. ISBN: 978-1-947493-80-3

Note: REGL.X410 replaced REGL.X404 Regulation of Medical Devices and Diagnostics. If you have established candidacy using the former requirements, you will not need to take REGL.X410. If you are interested in establishing candidacy using the new requirements, please contact student services. Student services will guide you on the steps needed to request REGL.X404 earned credits to count towards the updated program requirements.