Selling Products in Europe? Why an EU Authorized Representative is No Longer Optional
A single word change in EU legislation — “may appoint” became “shall appoint” — has turned the EU Authorized Representative from an optional administrative step into a mandatory requirement for many non-EU manufacturers. Here’s what an EU AR actually does, why the 10-year documentation rule matters, and how F2 Labs’ new EU Authorized Representative Service helps you stay compliant.
F2 Labs Named Top Medical Product Compliance & Certification Testing Lab 2026
F2 Labs has been recognized as the Top Medical Product Compliance & Certification Testing Lab 2026 by MedTech Business Review.
Your Router Might Be a Spy: FCC Cracks Down on Foreign-Made Devices
In a move that sounds like it came straight out of a cybersecurity thriller, the FCC has decided that your
FDA Gives Its Standards List a Tune-Up (Because Even Regulations Need Updates)
The U.S. Food and Drug Administration (FDA) has rolled out its latest refresh of the Recognized Consensus Standards List, and
EMC Testing for FDA 510(k): Common Mistakes That Delay Clearance
Every medical device team reaches the same moment: EMC testing is complete, the report looks good, and it feels like
Wellness Meets Regulation (But With a Smile): An Industry Insider’s Take on FDA General Wellness Policy
Every wellness startup eventually asks the same nervous question: “Are we about to become an FDA-regulated medical device… or can
Proposed Updates to MDR and IVDR for Europe
EU Wants Less Red Tape and More Medical Tech Magic (With Fewer Forms to Fill!) If you thought medical device
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