Author Archives: Keith Cooper

CE Marking: Your Electronic Product’s Passport to Europe

Posted on February 5, 2025 by Keith Cooper

If electrical products had passports, the CE mark would be their golden ticket to travel freely across Europe. But unlike that dusty old passport you forgot to renew, CE marking isn’t just a stamp—it’s a declaration of compliance with essential … Continue reading →

Posted in ATEX Directive 2014/34/EU, CE marking, EMC Directive 2014/30/EU, General Product Safety Regulation (EU) 2023/988, GPSR, GPSR (EU)2023/988, Low Voltage Directive 2014/35/EU, Machinery Directive 2006/42/EC, Machinery Regulation (EU)2023/1230, Medical Devices Regulation (EU)2017/745, PPE Regulation (EU) 2016/425, Pressure Equipment Directive 2014/68/EU, Radio Equipment Directive 2014/53/EU, REACH, RoHS Directive 2011/65/EU | Comments Off on CE Marking: Your Electronic Product’s Passport to Europe

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 →

Posted in EN 60601-1, FDA, Medical Devices Regulation (EU)2017/745 | Comments Off on Embracing AI in Healthcare: The FDA’s Guidance on Good Machine Learning Practice

What is an NRTL Field Label and What do I Need to Know About Them?

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 →

Posted in Field Label, Product Testing, SPE-1000, US Field Label | Comments Off on What is an NRTL Field Label and What do I Need to Know About Them?

The FDA and Common Electromagnetic (EM) Emitters – What You Need to Know

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 →

Posted in FDA, Product Testing | Comments Off on The FDA and Common Electromagnetic (EM) Emitters – What You Need to Know

IEC 60601-1-9 Environmentally Conscious Design – What is it?

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 →

Posted in CE marking, EN 60601-1, IEC 60601-1-9, Medical Devices Regulation (EU)2017/745 | Comments Off on IEC 60601-1-9 Environmentally Conscious Design – What is it?

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 certification 4200A as the safety standard for performance and … Continue reading →

Posted in Listing, Product Testing, UL 4200A | Comments Off on Reese’s Law – What You Need To Know

FDA Advises Medical Device Manufacturers to be Vigilant and Validate 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 →

Posted in FCC, FDA, Product Testing | Comments Off on FDA Advises Medical Device Manufacturers to be Vigilant and Validate Data

I Want to Send a Flatscreen Monitor to the EU, What Now?

Posted on January 30, 2024 by Keith Cooper

Navigating CE Compliance for entry into the EU can be daunting at times, because of the sheer number of regulations and Directives that may apply to your given product.  Without the help of a trusted testing partner (seriously, contact us … Continue reading →

Posted in CE marking, Consulting, EMC Directive 2014/30/EU, General Product Safety Regulation (EU) 2023/988, GPSR, GPSR (EU)2023/988, Low Voltage Directive 2014/35/EU, Prop 65, Radio Equipment Directive 2014/53/EU, REACH, UL 62368-1 | Comments Off on I Want to Send a Flatscreen Monitor to the EU, What Now?

Pacemakers and Electric Cars

Posted on April 27, 2023 by Keith Cooper

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 them going.  A new study questioned whether individuals who wear … Continue reading →

Posted in CE marking, Consulting, EMC Directive 2014/30/EU, EMC Testing, FCC, FDA, Radio Equipment Directive 2014/53/EU | Comments Off on Pacemakers and Electric Cars

ESD and Electric Vehicles (EVs) – New Challenges

Posted on January 5, 2023 by Keith Cooper

Electric vehicle (EV) technology continues to evolve, grow, and become more commonplace. Changes and an increase in popularity will continue, especially with the insertion of ethernet technology for data communication in those systems. ESD protection is extremely important; especially in … Continue reading →

Posted in CE marking, EMC Directive 2014/30/EU, EMC Testing, EN 60601-1, FCC, Low Voltage Directive 2014/35/EU, Machinery Directive 2006/42/EC, Machinery Regulation (EU)2023/1230, Medical Devices Regulation (EU)2017/745, Product Testing, Radio Equipment Directive 2014/53/EU | Comments Off on ESD and Electric Vehicles (EVs) – New Challenges