Blog

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

Partner Corner: What’s New at SIQ

Partner Corner: What’s New at SIQ New 9000 square meter facility and MET partnership provide more effective access to North American Certifications For more than 50 years, SIQ has provided comprehensive services for product testing & certification, management systems assessment, metrology, and training. Located in central Europe – Slovenia, SIQ maintains its international recognition and... Read More