Does Customs Really Check For RoHS in The EU?
Yes. I get an email every week from the European Commission’s Safety Gate that lists some of the most dangerous
Embracing AI in Healthcare: The FDA’s Guidance on Good Machine Learning Practice
Embracing the Future: The FDA’s Guidance on AI in Medical Devices As we enter an exciting era of technological advancement,
What is an NRTL Field Label and What do I Need to Know About Them?
If an Authority Having Jurisdiction (AHJ) or electrical inspector has ever informed you that you have failed your inspection or
The FDA and Common Electromagnetic (EM) Emitters – What You Need to Know
The FDA, per their Guidance Document published June 6, 2022, requires that medical device manufacturers be able to show that
Easy Approach to Essential Performance in Medical Devices for FDA
F2 Labs has many conversations every week with medical device manufacturers who are struggling to define Essential Performance for their
IEC 60601-1-9 Environmentally Conscious Design – What is it?
What exactly is the environmentally conscious design file? You need documentation/policies that show how you are addressing the requirements of
Navigating CE Certification for Entry Into the European Market
As both established and startup consumer electronics manufacturers look to expand their market reach, the European Union presents an enticing,
Reese’s Law – What You Need To Know
Reese’s Law was signed by President Biden on August 16, 2022 and as of March 19, 2024 all products
The Machinery Regulation(EU)2023/1230 vs. Machinery Directive 2006/42/EC – What Is New?
The Machinery Regulation (EU)2023/1230 was published in 2023 but does not formally replace the Machinery Directive 2006/42/EC until 2027. F2
Hazardous Location Evaluations – ‘Behind the Scenes’ Details about Intrinsic Safety
Today, I read an email from our HazLoc engineering department that I think is extremely useful not only for F2
FDA Advises Medical Device Manufacturers to be Vigilant and Validate Data
The U.S. Food and Drug Administration recently sent out an Open Letter to Industry to remind manufacturers of medical devices
I Want to Send a Flatscreen Monitor to the EU, What Now?
Navigating CE Compliance for entry into the EU can be daunting at times, because of the sheer number of regulations