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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

FAQs: IEC 62368-1 replacing IEC 60950-1 & IEC 60065. What you Should Know

What you should know about IEC 62368-1 HBSE FAQ IEC 62368-1 HBSE replacing IEC 60950-1 and IEC 60065: Frequently asked questions. Multimedia devices are rapidly converging and rapidly adopting new technology that enables better communication and performance. As a result, The line separating Audio/Visual equipment from IT products continues to be blurred. As new devices... Read More