Buckle up, folks—our favorite regulatory sheriffs at the FDA have dropped another massive rulebook, this time titled “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations.” If you’re
Embracing the Future: The FDA’s Guidance on AI in Medical Devices As we enter an exciting era of technological advancement, the role of artificial intelligence (AI) in medical devices stands
The FDA, per their Guidance Document published June 6, 2022, requires that medical device manufacturers be able to show that their product is immune to common Electromagnetic (EM) Emitters, such
F2 Labs has many conversations every week with medical device manufacturers who are struggling to define Essential Performance for their device. From our experience, the confusion around Essential Performance frequently
The U.S. Food and Drug Administration recently sent out an Open Letter to Industry to remind manufacturers of medical devices that they should always be vigilant in verifying the accuracy
Over the past decade, we have seen an explosion of popularity with various green technologies, and at the forefront of that are electric vehicles and the charging stations that keep
A comprehensive guide into the listing standards that are required after testing to compliance marks.
F2 Labs is officially an ASCA-accredited testing laboratory! We are one of only 17 labs approved by the FDA. This program will help increase product safety for the end-user and shorten the time it takes for FDA approval of your product.
This is the first time in history that the FDA has had a list of approved labs. F2 Labs is officially an ASCA-accredited testing laboratory.
It is safe to say that COVID-19 has affected everyone in the world. F2 Labs immediately joined the fight and offered pro-bono services to our customers who are working to
