What Is Systems Engineering in Medical Devices (And Why Your Project Needs It) Technical innovation is often the easy part…
When a company believes they’re ready to take their medical device to market, they often discover that what they thought…
In a significant move to align with international standards, the U.S. Food and Drug Administration (FDA) has released the Quality Management…
Here’s the situation: your medical device design and internal testing are complete. The only testing left to complete is…
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)…
The 3rd Edition of the Medical Device Risk Management standard, ISO 14971:2019, was approved May 2019 and replaces the second edition (ISO…
One of systems engineering’s core functions is to understand the user needs for a product or service, and seamlessly translate…
As noted in my previous blog post, I attended and presented at the INCOSE Conference on Agile in Healthcare…