Demystifying Medical Device Compliance
Medical device compliance is hard....but not impossible. Here we share helpful resources to support your product development lifecycle.
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FDA's New Draft Guidance for AI/ML - what's in it?
The FDA just released a new draft guidance about what to include in your regulatory submissions for artificial intelligence and machine learning-enabled medical devices. Here's what they expect.
What are the requirements for a software as a medical device?
Many medical devices developed today involve software in some capacity. What's special about medical device software?
How do you keep your investors at ease while communicating with the FDA?
How to communicate with investors about the ongoing FDA process.
I’m building a medical device. Do I *need* to do a clinical study?
Building a medical device and wondering if you'll need to perform a clinical study? Depends on your device and the claims you want to make - check out some tips in this article.
Software as a Medical Device versus outside software
Wondering about the difference between software as a medical device or software in your medical device? Check out this guide to learn some medical device software best practices.
My product is Class I, do I still need a Quality System?
While there are some Class I devices that do not require a quality system, it's not that simple. Learn more about how to determine if you need a quality system for your Class I device.
How long does it take to get an IRB study approved?
Wondering how long it will take to your study approved by an Institutional Review Board?
How long does it take to get a medical device approved?
Wondering how long it takes before you can sell your medical device? Check out this guide for some tips.
Key Questions When Developing Software as a Medical Device
If you're developing software as a medical device, check out this post to learn about important questions to ask before you start development.
The Compliance Journey, Part 2: Transitioning to Full Compliance
I’m ready for full compliance, how do I make sure I'm following all the regulations? Find out during this webinar event.
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