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.
How medical devices and software are regulated around the world. How medical software is designed, developed, and implemented in the real world.
Syllabus
Syllabus - What you will learn from this course
Week 1
Introduction to Medical Software and Digital Health
Week 2
Medical Software Regulation (FDA and IMDRF)
Week 3
The Healthcare Environment (EHR, PACS, Data Privacy, and Cybersecurity)
Week 4
Quality and Risk Management
Week 5
Software Development Life Cycle
Week 6
User Needs & System Requirements
Week 7
Software Architecture Design and Usability Engineering
Week 8
Construction and Testing
Week 9
Probability and Statistics
Week 10
Software Validation, Deployment, Maintenance and Retirement
Week 11
Machine Learning
Week 12
Business and Management Issues
Week 13
Optional Supplement: Case Studies
Week 14
Optional Supplement: Expert Interviews
FAQ
When will I have access to the lectures and assignments?
Access to lectures and assignments depends on your type of enrollment. If you take a course in audit mode, you will be able to see most course materials for free. To access graded assignments and to earn a Certificate, you will need to purchase the Certificate experience, during or after your audit. If you don't see the audit option:
What will I get if I purchase the Certificate?
When you purchase a Certificate you get access to all course materials, including graded assignments. Upon completing the course, your electronic Certificate will be added to your Accomplishments page - from there, you can print your Certificate or add it to your LinkedIn profile. If you only want to read and view the course content, you can audit the course for free.
Is financial aid available?
Yes. In select learning programs, you can apply for financial aid or a scholarship if you can’t afford the enrollment fee. If fin aid or scholarship is available for your learning program selection, you’ll find a link to apply on the description page.
Reviews
This course from Yale University is really amazing as it covers all aspects of Software Medical devices starting from Designing to clinical aspects and regulatory requirements.
Great course even for people without a programming background (such as myself). The Quizzes were also very well designed
Great course. Thank you Coursera for the opportunity to learn more everyday.
