Category Archives: CE marking

Embracing AI in Healthcare: The FDA’s Guidance on Good Machine Learning Practice

Posted on September 30, 2024 by Keith Cooper

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 out as particularly transformative. The FDA’s recent guidance on “Good … Continue reading →

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NRTL Field Evaluation and Labeling

Posted on September 12, 2024 by Keith Cooper

If an Authority Having Jurisdiction (AHJ) or electrical inspector has ever informed you that you have failed your inspection or that you require a “UL or CSA Certification” or that your equipment must be “UL/CSA Certified” or “UL/CSA Labeled” we … Continue reading →

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Common Electromagnetic (EM) Emitters

Posted on August 23, 2024 by Keith Cooper

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 as RFID Readers, Near-field Communication (NFC) systems, metal detectors, Electronic … Continue reading →

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Easy Approach to Essential Performance in Medical Devices for FDA

Posted on August 15, 2024 by Cristina Akinwale

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 stems from the fact that what a device manufacturer views … Continue reading →

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Environmentally Conscious Design

Posted on August 14, 2024 by Keith Cooper

What exactly is the environmentally conscious design file?  You need documentation/policies that show how you are addressing the requirements of that standard.  You really should use the standard as guidance (IEC 60601-1-9).  Here is some good information on what this … Continue reading →

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Navigating CE Certification for Entry Into the European Market

Posted on July 19, 2024 by Intero Digital

As both established and startup consumer electronics manufacturers look to expand their market reach, the European Union presents an enticing, lucrative growth opportunity. Entry into this market comes with its prerequisites, however, one of which is CE certification. This certification … Continue reading →

Posted in ATEX Directive 2014/34/EU, CE marking, Consulting, EMC Directive 2014/30/EU, Low Voltage Directive 2014/35/EU, Machinery Directive 2006/42/EC, Machinery Regulation (EU)2023/1230, Medical Devices Regulation (EU)2017/745, Pressure Equipment Directive 2014/68/EU, Radio Equipment Directive 2014/53/EU, RoHS Directive 2011/65/EU | Comments Off on Navigating CE Certification for Entry Into the European Market

Reese’s Law – What You Need To Know

Posted on July 3, 2024 by Keith Cooper

Reese’s Law was signed by President Biden on August 16, 2022 and as of March 19, 2024 all products that incorporate button batteries or coin cell batteries must comply with UL 4200A as the safety standard for performance and labeling … Continue reading →

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The Machinery Regulation(EU)2023/1230 vs. Machinery Directive 2006/42/EC – What Is New?

Posted on June 25, 2024 by Peter Jolles

The Machinery Regulation (EU)2023/1230 was published in 2023 but does not formally replace the Machinery Directive 2006/42/EC until 2027. F2 Labs performed a deep dive into the two EU regulations to figure out what is new, what is staying, and … Continue reading →

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HazLoc Evaluations – Behind the Scenes Information about Intrinsic Safety

Posted on June 20, 2024 by Peter Jolles

Today, I read an email from our HazLoc engineering department that I think is extremely useful not only for F2 Labs personnel, but also for our clients who are working on what is required and how to comply. Your first … Continue reading →

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FDA Reminds Manufacturers to Verify Third-Party Test Data

Posted on February 29, 2024 by Keith Cooper

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 of third party testing data that they are using for … Continue reading →

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