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SURINA GULATI, MBEE, is a quality systems engineering lead at iRhythm Technologies with more than eight years of experience in quality, regulatory compliance, and digital health within the medical device industry. She is an Exemplar Global¨Ccertified Lead Quality Management Systems Auditor and an adjunct instructor. She also serves as an advisory board member for the Regulatory Affairs and Medical Device Quality and Design certificate programs at °®¶¹´«Ã½ Silicon Valley Extension. Her published work includes contributions to Fundamentals of Medical Device Regulations: A Global Perspective and multiple industry articles on regulatory best practices.

Her professional background roles include positions at Align Technology, a Stanford StartX AI/ML startup, and Thermo Fisher Scientific. She holds a master's degree in Biotechnology & Entrepreneurship from Johns Hopkins University and a bachelor's degree from UC Berkeley. She was honored with the RAPS Rising Star Award in 2024.

Surina Gulati, Instructor, Medical Device Design Certificate Program
Surina Gulati's courses currently open for enrollment

Effective Auditing: Interviewing, Influence & Audit Psychology

MEDD.X412
$750
  • Live-Online Attend via Zoom at scheduled times.
Schedule
Date Start Time End Time Meeting Type Location
Thu, 04-09-2026 6:00pm 9:00pm Live-Online REMOTE
Thu, 04-16-2026 6:00pm 9:00pm Live-Online REMOTE
Thu, 04-30-2026 6:00pm 9:00pm Live-Online REMOTE
Thu, 05-07-2026 6:00pm 9:00pm Live-Online REMOTE
Thu, 05-14-2026 6:00pm 9:00pm Live-Online REMOTE
 

3/2/26: Course postponed. See full schedule for details.

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.

No meeting on April 23, 2026. 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.

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Prerequisites / Skills Needed

Prerequisites:

  • MEDD.X407: Quality Management Systems for Medical Devices: ISO 13485 and FDA Requirements
Associated Program(s)