Author Archives: Keith Cooper

FDA Advises Medical Device Manufacturers to be Vigilant and Validate Data

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

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

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

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

WPT for EVs and the Effect on AM Radio Broadcasts

As more and more electric vehicles (EVs) continue to be utilized both by the public and by government agencies to help reduce our carbon footprint and reduce greenhouse emissions, the infrastructure used to power these vehicles continues to grow. An … Continue reading

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Enforcement of the UKCA Mark is Postponed

On November 14, 2022 the UK announced that use of the UKCA Mark (for Great Britain) is to be postponed an additional two years until December 31, 2024.  Previously, mandatory use of the mark and scheme was supposed to be … Continue reading

Posted in ATEX Directive 2014/34/EU, CE marking, 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, REACH, RoHS Directive 2011/65/EU, UKCA | Comments Off on Enforcement of the UKCA Mark is Postponed

Changes to the Korean EMC standard KS C 9814-1

On May 31, 2022, a new version of KS C 9814-1 was issued and is applicable to products that fall in the category of household appliances, electric tools, and other similar apparatus.  Examples of equipment that fall in this category … Continue reading

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What Now?

A comprehensive guide into the listing standards that are required after testing to compliance marks. Continue reading

Posted in ATEX Directive 2014/34/EU, CE marking, EMC Directive 2014/30/EU, FCC, FDA, Field Label, GPSR, GPSR (EU)2023/988, International Testing, 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, Prop 65, Radio Equipment Directive 2014/53/EU, REACH, RoHS Directive 2011/65/EU, SPE-1000, UKCA, US Field Label | Comments Off on What Now?

What is a CE marking? Does My Product Need One?

The CE mark is a mandatory European marking for certain product groups to indicate conformity with the essential requirements set out in European Directives. To use the CE mark on a product, the manufacturer must draw up an EU Declaration of … Continue reading

Posted in ATEX Directive 2014/34/EU, CE marking, EMC Directive 2014/30/EU, EMC Testing, GPSR, GPSR (EU)2023/988, Lasers, 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, Product Testing, Radio Equipment Directive 2014/53/EU, RoHS Directive 2011/65/EU | Comments Off on What is a CE marking? Does My Product Need One?

Harmonizing UL 60335-2-40/CSA C22.2 No. 60335-2-40 with EN 60335-2-40

For years, more niche product categories have suffered from not having harmonized testing standards.  What this means for manufacturers is more expensive and extensive regulatory exercises because the standards for the US, Canada, and the European Union are all different.  … Continue reading

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