Tag Archives: IEC 60601
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
