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Pathfinder to Speak on Agile for Medical Software in FDA Regulated Environments
Agile emphasizes minimal documentation, a lot of verbal communication and rapid feedback loops to increase software quality, reduce waste and speed development. FDA regulations run counter to this...
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Agile In FDA Regulated Medical Software – Methodology
Methodology “The analysis of the principles of methods, rules, and postulates employed by a discipline” For software companies these day it seems that its not a hard choice to follow Agile principles....
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Agile in FDA Regulated Medical Software – Have Some Class
The FDA states that a medical device is a product that is used for medical purposes in patients, in diagnosis, therapy, or surgery. As opposed to a pharmaceuticals, who use the body’s metabolism,...
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Agile in FDA Regulated Medical Software – Checklists
Lets be honest: Checklists aren’t the most exciting topic to blog about. However, in the context of regulation they become interesting. Everybody loves checklists and hates them at the same time. It’s...
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Agile and the FDA: Faster, Better Development for Medical Devices
We presented our approach to implementing agile in an FDA regulated environment to a joint meeting of the Chicago Agile Project Management Group and Health 2.0 Group last week. This is based on our...
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Agile in FDA Regulated Medical Software – Functional Testing vs Technical...
Testing is a crucial part of all software development. If you don’t believe this you are likely just starting your career or haven’t had to support an application in production with users. It becomes...
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Agile in FDA Regulated Medical Software – Its Not What You Wear. Its How You...
Its not what you wear. Its how you wear it. Photo by country_boy_shane I have to thank Tavi Scandiff-Pirvu for coining this expression as it relates to regulated software development. As long as you...
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Agile in FDA Regulated Medical Software – Sweat the Details
Very few people in the software development community have issues with maintaining good attention to the details. However, I bet those who live in the regulated software community view the “normal”...
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Agile in FDA Regulated Medical Software – Partnering
This may be generic advice, but it might not be a familiar concept for those in IT working within a large organization doing validated software: Once you adopt the practices described in my previous...
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