Guidance, Standards, and Regulation
Legacy Medical Device Cybersecurity: Why Doing Nothing Is No Longer an Option Medical devices weren’t built to last 20+ years,…
What Is Systems Engineering in Medical Devices (And Why Your Project Needs It) Technical innovation is often the easy part…
So, you have a medical device that you are ready to put on the market? You’ve identified a product…
When trying to determine FDA medical device classification, there are a few ways to get information and feedback from…
Changes to FDA recognized consensus standards this year may catch many medical device manufacturers off-guard when preparing their medical…
In June of 2022 the FDA issued an updated guidance for “Electromagnetic Compatibility (EMC) of Medical Devices”. This guidance…
The FDA has identified a list of Class I and Class II medical devices that are exempt from 510(k)…
We’ve kicked off company operations in March. It’s been a long time coming! One of our first tasks is to…