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.
OB
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.
PS
This is the best course for those who wants to know all about medical devices, and their related regulations.
NM
A great course to learn about basics and working Medical Software. Helped me to learn many things regarding my field. I highly recommend this to everyone ^-^
DS
Prof X. Papademetris is excellent teacher, to the point, clear and precise. The content of this course is perfect for a newbie in the field. Thank you, Coursera, for a wonderful treat.
EN
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
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.
BA
it would be great if we can transfer this certificate into a degree with yale university
AS
Excellent high level overview of all aspects that go into making medical software.
HP
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.
MJ
The course content is good and well organised. Intended purpose is served by the course and the presenters.
UF
Excellent introductory course for medical software! humble and down to earth teacher
SN
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.
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Great course even for people without a programming background (such as myself). The Quizzes were also very well designed
I thoroughly enjoyed this course and appreciated Prof. Papademetris' engaging teaching style. The course itself is worth 5 stars. Unfortunately after many weeks of trying, I am not able to access my certificate, and there is no way to contact a human to help. My credit card even got charged for $1 unbeknownst to me, which caused me to have to cancel it and get a new one. This has been a very frustrating and disappointing experience.
In my case it has been enriching.
I think it gives a complete view and starting point if you have little or no information about Medical Software. It is a good starting point and 100% recommended.
after completion certificate not available
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.
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.
A great course to learn about basics and working Medical Software. Helped me to learn many things regarding my field. I highly recommend this to everyone ^-^
It's really good course on Medical Software, it's more that just "introduction". Big thanks to the Yale team!
Thank you for sharing this information. I was a little dismayed that this didn't include more practical information in terms of the various settings for inputting CPT & ICD-10 codes, or perhaps other shortcuts for charting. If there are any other hands-on courses that allow for one to interpret imaging (on a non-fixed multiplanar axis for MRI & MRA studies), I would love to learn more about that. Perhaps there's a sandbox version of a DICOM, or PACS that are separate to an Anatomage table that can be used to work through those modalities, especially to work through comparative analysis to better reinforce the advantages of transparency with multimodality imaging software prior, peri- & subsequent to any major surgical procedures.
The Introduction to Medical Software course taught by professor Xenophon Papademetris is a very comprehensive, informative and well organized class on Medical Device/Software. This course has the potential to short-circuit multiple years of on-the-job experience into one (semester) course and help build a strong foundation for future (medical) software/engineering development or regulatory affairs career. I strongly recommend the course, as well as the tremendous links to other relevant resources. Thanks again to the professor and Yale University for making this course available on Coursera.
Overall a very comprehensive introduction. Well structured and lots of reading material (not good was that some of the reading material had to be purchased). Prof. Papademetris talks very fast and subtitles really need to be edited. There were so many mistakes e.g. sexual device instead of surgical device, it was better to just rewind the passages that you did not understand until you did.
Really great course for everyone who wants to have an overview of all the aspects related to the SaMD. It is quite detailed, therefore it is a good training for people who already have some prior basic knowledge about the SaMD. Some articles are hard to read having no engineering/programming background, but still very interesting to see this "world".
This program has given me an in-depth understanding of the regulatory environment around medical software worldwide and the practical process of designing, developing, and deploying such software in real-world scenarios. I'm thrilled to apply this knowledge to my future work in the medical technology industry.
Excellent information delivered clearly and professionally by an amazing professor. Really enjoyed learning the material. The one "ask" is for a way to buy the book they keep showing! It is not yet available and I think many people, including me, would love to get a copy of it!
It is a great introductory course about Medical softwares. This course helped me a lot to find improvement points in the software development process at my work. Congratulations for prof. Papademetris and all the involved professional in this course development!
Excellent course to learn about everything you need to know about Medical Software.
There is a good mix between videos, readings and questions to validate the acquired knowledge.
Highly recommended for people to get to start learning about the requirements.
Great introduction to the basics! I do wish it would get updated to reflect new guidances and best practices published by the main governing bodies when there are big changes, some of the content and case studies are just a little stale.
This course should be called a Roadmap. It is more than an Introduction. Amazing material, put together and making flawless for a new researcher to navigate in the regulatory process. Many Thanks to Prof. Papademetris@
It is a complete course that one can take even if one is not an expert in some of the areas that are involved. Also, it has useful information about the regulatory process of developing medical software.
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.