Blog

COVID-19 Updates

Update on COVID-19 Coronavirus Effects on Eurofins E&E North America Business Operations In the face of the rapidly evolving COVID-19 Coronavirus pandemic, our company remains focused on safeguarding the health and safety of our employees and customers. The data that comes from Eurofins E&E laboratories directly supports the greater health and well-being of the general... Read More

Michael Chang Presents at IEEE International Symposium on Product Compliance Engineering

Each year, the IEEE Product Safety Engineering Society hosts a premier symposium which focuses on a number of topics including Compliance, EMC and Wireless, Medical, and Global Market Access. During the symposium, technical information related to product safety is discussed and disseminated to attending product safety and design engineers. This year’s meeting was held from... Read More

FAQ: Risk Management for IEC 60601-1

FAQ: Risk Management for IEC 60601-1 What you need to know about Risk Management for medical devices What is Risk Management in 60601? Risk management is a series of risk evaluations performed by the manufacturer, based on ISO 14971, which are undertaken and documented throughout the design, production and post-production process of medical equipment. The... Read More

FAQ: FDA Laser Notice No. 50

FAQ: FDA Laser Notice No. 50 What you need to know about Laser Safety for United States and International markets What is FDA Laser Notice No. 50? Laser Notice No. 50 is an FDA guidance document that determines what components of IEC 60825 and IEC 60601-2-22 can be used to meet requirements found in 21CFR1040... Read More

IEC/EN/UL/CSA 61010-1 Third Edition

Since the release of the 3rd Edition, there have been varying interpretations regarding if and when a Risk Assessment is a requirement or merely an option. The disagreements have occurred between different Certification Bodies, between test houses and manufacturers, and even within specific discrete entities. Given this previous uncertainty and the possibility of inconsistently imposed... Read More