NFPA 790 vs. NFPA 791: A Field Evaluator’s Guide to This Dynamic Duo
If you’ve ever been summoned to inspect an unfamiliar piece of equipment in the field—armed with nothing but a safety
Why Does EMC Testing of a Medical Device to IEC 60601-1-2, AIM 7351731, and/or Common EM Emitters Testing Have to be Conducted in Both Charging and Battery Modes? (Even When the Device Is Basically Just Napping on the Charger)
If you’ve ever prepped a medical device for a regulatory review, such as an FDA 510K submission, you’ve probably hit
Is My Specially Designed Equipment in the Scope of RoHS?
We assist clients with their CE marking obligations daily at F2 Labs. This often means that we get into the
Why ISO/IEC 17025 Accreditation Matters for Electrical Safety & EMC Testing | F2 Labs
Electrical safety and EMC testing might not sound thrilling at first (unless you dream in oscilloscopes), but these tests are
We Offer CE Marking Training For Your Organization
F2 Labs offers onsite, and occasionally remote, CE marking Training for your company. Recently, I conducted our CE marking Training
So You Need to Field Evaluate Your Equipment – What You Need to Know
If an Authority Having Jurisdiction (AHJ) or electrical inspector has ever informed you that you have failed your inspection or
Corrosion | Salt Fog Testing: Like taking your product to the beach
Imagine this: your brand-new, bright, glistening product steps into a chamber. The door closes. Inside, it’s not the day at
Essential Performance: What It Is, Why It Matters, and When You Can Say “No Thanks”
Let’s talk about Essential Performance—the term that sounds like it belongs in a motivational poster but is actually a cornerstone
Adapting to Evolving U.S.-China Regulatory Dynamics
Medical device companies operating across U.S. and Chinese markets are facing a rapidly shifting regulatory environment. As geopolitical tensions between
REACH/RoHS and Continuing Compliance
* Until August 15th, if you mention this blog post we will offer special pricing (20% off) your full REACH
FDA Enforcement Flags Data Integrity Risks at Overseas Labs
The U.S. Food and Drug Administration (FDA) has issued formal warning letters to two overseas third-party labs for serious violations
Cybersecurity and the new Radio Equipment Directive
So, manufacturers, get your cybersecurity capes on. The EU is coming for your gadgets—and it means business. Brace Yourselves: The