In a significant move to align with international standards, the U.S. Food and Drug Administration (FDA) has released the Quality Management…
With the FDA’s new regulation enforcement of laboratory developed tests (LDTs) beginning May 6, 2025, laboratories across the country are…
While many laboratories are understandably concerned about the FDA’s new laboratory developed test (LDT) regulations, and there is much uncertainty…
With the FDA’s laboratory developed test (LDT) regulation enforcement, many laboratories are asking about exemptions. However, it’s crucial to understand…
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…