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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 blogs about regulated software, you will find that you aren’t working alone anymore. The tight feedback cycles allow you to regularly check-in with the business and involve them in building the software. Once this h
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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” software world as quite sloppy. Attention to detail is a matter of life and death for a medical device. Because of this, the entire software community does a good job maintaining checks and balances. I have thr
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Agile in FDA Regulated Medical Software – Its Not What You Wear. Its How You Wear It.

Its not what you wear. Its how you wear it. I have to thank Tavi Scandiff-Pirvu for coining this expression as it relates to regulated software development. As long as you use industry standard methods, the FDA allows you to determine the rules that you are going to follow. If you want to have 15 exhaustive steps in order to build each piece of functionality the FDA will say, “Go do it. Just document each step
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Agile in FDA Regulated Medical Software – Functional Testing vs Technical Testing

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 doubly important in regulated environments like the ones for medical devices. This is because testing for regulated software serves multiple purposes. There is the usual software product development reasons
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Turnover…..JIT docs

You started a new job recently. Your organization has a some “legacy” apps, plus they’re working on a new batch using some cutting-edge technology. You’re assigned to a cool team with some hot-shot developers and ready do get down to work. Suddenly, on day two, your manager walks by to let you know that the lead (and only developer) on one of the apps has resigned and will be leaving next week. Your manager asks you
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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 really easy to make them and just as easy to forget to use them. Later on, after the emergency and/or reason they were created has subsided, using the checklists becomes a ceremony – something that mus
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Just one……

How many time have we heard some form of the phrase “it just a one line change”? Or “it shouldn’t effect anything else”? I think we know the all to frequent result…..”I can’t believe THAT broke……!!”. Good developers write automated tests to help surface side-effects like this before they get into production and cause real damage. Good developer refactor code mercilessly to make modifications less er
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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, medical devices act mechanically or chemically. The FDA’s role in this is to assure the safety and effectiveness of devices. Keep this in mind while going through the process (they are not just to make your life
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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. With some practice, or hiring a consultant, you can learn Agile practices and employ them as well. Its an entirely different animal to decide you are going to use Agile practices in a regulated environment t
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Agile In FDA Regulated Medical Software – It can be done!

We have all heard that developing software utilizing Agile principles yields high quality, working software in customers’ hands quickly. It is widely believed that utilizing Agile practices leads to better, cheaper software than waterfall methods in most instances. However, those who write software that must be reviewed by the FDA know that, at first look, the FDA regulations run counter to this approach. They
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