Introduction to Medical Software Development and Regulation
Master medical software development, from regulatory compliance to implementation. Learn FDA guidelines, quality management, and healthcare IT integration.
Master medical software development, from regulatory compliance to implementation. Learn FDA guidelines, quality management, and healthcare IT integration.
This comprehensive course from Yale University covers the entire spectrum of medical software development and regulation. Students learn about FDA requirements, healthcare IT systems, and software development lifecycles specific to medical applications. The curriculum includes quality management systems, risk assessment, cybersecurity, and data privacy considerations. Through real-world case studies and expert insights, participants gain practical knowledge of medical software design, validation, and deployment in healthcare settings.
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English
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What you'll learn
Understand medical device regulations worldwide
Master medical software design and development processes
Implement quality management systems and risk assessment
Navigate healthcare IT infrastructure and integration
Apply cybersecurity and data privacy principles
Develop regulated medical software solutions
Skills you'll gain
This course includes:
594 Minutes PreRecorded video
11 assignments
Access on Mobile, Tablet, Desktop
FullTime access
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There are 14 modules in this course
This comprehensive course provides a thorough introduction to medical software development and regulatory compliance. The curriculum covers essential topics including FDA regulations, healthcare IT systems, quality management, and cybersecurity. Students learn about the complete software development lifecycle for medical applications, from user needs assessment to validation and deployment. Special emphasis is placed on risk management, clinical trials, and emerging technologies like AI/ML in healthcare. The course includes real-world case studies and expert perspectives from industry professionals.
Introduction to Medical Software and Digital Health
Module 1 · 3 Hours to complete
Medical Software Regulation (FDA and IMDRF)
Module 2 · 2 Hours to complete
The Healthcare Environment
Module 3 · 3 Hours to complete
Quality and Risk Management
Module 4 · 2 Hours to complete
Software Development Life Cycle
Module 5 · 2 Hours to complete
User Needs & System Requirements
Module 6 · 1 Hours to complete
Software Architecture Design and Usability Engineering
Module 7 · 3 Hours to complete
Construction and Testing
Module 8 · 2 Hours to complete
Probability and Statistics
Module 9 · 2 Hours to complete
Software Validation, Deployment, Maintenance and Retirement
Module 10 · 2 Hours to complete
Machine Learning
Module 11 · 5 Hours to complete
Business and Management Issues
Module 12 · 3 Hours to complete
Optional Supplement: Case Studies
Module 13 · 2 Hours to complete
Optional Supplement: Expert Interviews
Module 14 · 10 Minutes to complete
Fee Structure
Payment options
Financial Aid
Instructor
Professor of Radiology and Biomedical Engineering at Yale University
Xenophon Papademetris is a distinguished professor at Yale University, where he teaches in the fields of Radiology and Biomedical Imaging, as well as Biomedical Engineering. His research focuses on medical image analysis, contributing significantly to advancements in the field. He coordinates the development of the Yale BioImageSuite Web software package, which enhances medical imaging capabilities.In addition to his research, Professor Papademetris teaches a course titled "Medical Software Design" and is the first author of the book "Introduction to Medical Software: Foundations for Digital Health, Devices and Diagnostics," published by Cambridge University Press in 2022. His work bridges the gap between technology and healthcare, aiming to improve digital health solutions
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4.8 course rating
231 ratings
Frequently asked questions
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