Getting Started

If you have absolutely no clue about medical devices and where to start, this is the place to get you started! You’ll learn about coming up with the right classification for your medical device, writing your intended use, accessing standards for little money, and many other exciting things.
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QMS Software

What the hell is QMS software, and do you need it? And how do you learn more about QMS software without falling asleep or being bombarded by sales calls from shady enterprise QMS vendors? Difficult questions indeed.
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Regulatory News

Regulatory news and other exciting things happening in the regulatory world. Generally speaking, most updates here are about how your life is about to get more complicated and you'll be writing even more documentation. But there are some much-appreciated exceptions!
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Discussions about Ruby on Rails, software development and other engineering topics.
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