Approximately 70 percent of software-related recalls are due to software design issues that can be mitigated by using risk-based software development lifecycle processes.

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POOJA KARTIK, BS, teaches at AAMI and is vice president of Quality and Regulatory at Triple Ring Technologies. She started her medical devices career working in the embedded software in the Medronic Quality, Regulatory, and Program Management offices in 2001. Since then, she has held both strategic and tactical roles in pre-market and post-market quality, medical device software development life cycle, risk management, GxP software, computer systems validations, software engineering, software quality engineering, and regulatory compliance. She is a recipient of the AAMI 2008 Technical Contributor Award for IEC 62304. Pooja earned a Bachelor of Science degree in Computer Science from the University of Akron and completed an executive education in Digital Transformation from Harvard Medical School. She is passionate about innovation, patient safety, and solving hard problems and is currently pursuing Executive Education in Business Management LEAD Program at Stanford University Graduate School of Business.

Pooja Kartik
Pooja Kartik's courses currently open for enrollment

Risk Management for Regulated Industries

MEDD.X409
$875
  • Live-Online Attend via Zoom at scheduled times.
Schedule
Date
Start Time
End Time
Meeting Type
Location
Tue, 01-20-2026
6:30pm
9:30pm
Live-Online
REMOTE
Tue, 01-20-2026
6:30pm
9:30pm
Live-Online
REMOTE
Tue, 01-27-2026
6:30pm
9:30pm
Live-Online
REMOTE
Tue, 01-27-2026
6:30pm
9:30pm
Live-Online
REMOTE
Tue, 02-03-2026
6:30pm
9:30pm
Live-Online
REMOTE
Tue, 02-03-2026
6:30pm
9:30pm
Live-Online
REMOTE
Tue, 02-10-2026
6:30pm
9:30pm
Live-Online
REMOTE
Tue, 02-10-2026
6:30pm
9:30pm
Live-Online
REMOTE
Tue, 02-17-2026
6:30pm
9:30pm
Live-Online
REMOTE
Tue, 02-17-2026
6:30pm
9:30pm
Live-Online
REMOTE
Tue, 02-24-2026
6:30pm
9:30pm
Live-Online
REMOTE
Tue, 02-24-2026
6:30pm
9:30pm
Live-Online
REMOTE
Tue, 03-03-2026
6:30pm
9:30pm
Live-Online
REMOTE
Tue, 03-03-2026
6:30pm
9:30pm
Live-Online
REMOTE
Tue, 03-10-2026
6:30pm
9:30pm
Live-Online
REMOTE
Tue, 03-10-2026
6:30pm
9:30pm
Live-Online
REMOTE
Tue, 03-17-2026
6:30pm
9:30pm
Live-Online
REMOTE
Tue, 03-17-2026
6:30pm
9:30pm
Live-Online
REMOTE
Tue, 03-24-2026
6:30pm
9:30pm
Live-Online
REMOTE
Tue, 03-24-2026
6:30pm
9:30pm
Live-Online
REMOTE
 

黑料不打烊

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.
 

Validating Software for Medical Devices and Emerging Technologies

MEDD.X410
$800
  • Live-Online Attend via Zoom at scheduled times.
Schedule
Date
Start Time
End Time
Meeting Type
Location
Sat, 02-28-2026
10:00am
3:30pm
Live-Online
REMOTE
Sat, 02-28-2026
10:00am
3:30pm
Live-Online
REMOTE
Sat, 03-07-2026
10:00am
3:30pm
Live-Online
REMOTE
Sat, 03-07-2026
10:00am
3:30pm
Live-Online
REMOTE
Sat, 03-14-2026
10:00am
3:30pm
Live-Online
REMOTE
Sat, 03-14-2026
10:00am
3:30pm
Live-Online
REMOTE
Sat, 03-21-2026
10:00am
3:30pm
Live-Online
REMOTE
Sat, 03-21-2026
10:00am
3:30pm
Live-Online
REMOTE
 

黑料不打烊

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.

Required Text:
Introduction to Medical Software, Xenophon Papademetris, Ayesha N. Quraishi and Gregory P. Licholai, Cambridge University Press, 2022. ISBN: 9781009090148

Associated Program(s)