Monthly Archives: February 2025

Cracking the Code: How to Survive the FDA’s AI-Enabled Medical Device Guidance and Maintain Your Sanity

Posted on February 7, 2025 by Keith Cooper

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 still awake after reading that title, congratulations! This document is … Continue reading →

Posted in FDA | Comments Off on Cracking the Code: How to Survive the FDA’s AI-Enabled Medical Device Guidance and Maintain Your Sanity

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