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Yale University

Introduction to Medical Software

In this class, we present a broad overview of the field of medical software. You will learn from Yale professors and a series of industry experts who connect the course concepts to their real world applications. We begin by discussing medical device regulatory structures, data privacy and cybersecurity regulations, and key support technologies such quality management systems and risk management. We then take a detailed look at the medical software life cycle, starting with identifying user needs, mapping these to system requirements and then the process of software design, coding, testing and validation. We continue by exploring issues related to the use of machine learning techniques in medical applications from both a software engineering and a regulatory perspective. We conclude with a discussion of the business and management issues in this area focusing on the impact on digital health on modern healthcare and issues related to starting new ventures. This is a class aimed at either third- or fourth-year undergraduates in computer science, biomedical engineering, and related fields, and to junior software engineers currently either working in, or interested in moving to, the medical device industry.

Status: Risk Management
Status: Software Testing
IntermediateCourse38 hours

Featured reviews

BA

5.0Reviewed Oct 1, 2023

it would be great if we can transfer this certificate into a degree with yale university

JS

5.0Reviewed Mar 12, 2024

Outstanding organization & content throughout this course.I would be very interested in an advanced or complementary offering from Yale in the Bioinformatics space.Thank you so much, Yale Online!!

PS

5.0Reviewed Aug 28, 2023

This is the best course for those who wants to know all about medical devices, and their related regulations.

EN

5.0Reviewed May 26, 2025

Great course that manages to explain everything from the basics to the complex issues within the SaMD field. It was well-structured, easy to follow and very interesting!

CA

5.0Reviewed Feb 8, 2024

Great introduction to the challenges of developing software as a medical device. A lot of material for further study and great high level introduction to the most relevant regulations and standards.

RP

5.0Reviewed Aug 12, 2022

Great course even for people without a programming background (such as myself). The Quizzes were also very well designed

UF

5.0Reviewed Jan 28, 2022

Excellent introductory course for medical software! humble and down to earth teacher

SP

5.0Reviewed Jun 17, 2023

Very informative and engaging - Must do for all the people wanted to go software as a Medical device

SN

5.0Reviewed Aug 20, 2024

It is a great course. I have a PhD in Biomedical Sciences and this course was very helpful for me to understand the other side of Medical Software.

OB

5.0Reviewed Aug 11, 2024

The course is eye opening to every regulations guiding the development of a medical software and I do recommend it to as many who desires a career in the medical field whether engineering or sciences.

NB

5.0Reviewed Mar 10, 2023

It's a great course from Yale and it helped me to enhance my knowledge in the biomedical field. I would like to give special thanks to professor and coursera team.

DL

5.0Reviewed Sep 12, 2024

Fantastic Program. As an MD it helps me inderstand where it is all coming from and where it is going.

All reviews

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