Tag Archives: risk management

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

2012 ICPHSO Meeting and Symposium Addresses Global Regulatory Issues

The 2012 International Consumer Product Health and Safety Organization (ICPHSO) Annual Meeting and Training Symposium in Orlando moved into Workshop Day yesterday.  Some of the topics that were addressed: Global regulatory outlook Comparing Canadian and U.S. Consumer Product Safety Law EU Directives related to toys Effective recalls Risk management Global product safety strategies Hazardous substance regulations... Read More

Medical Product Safety Training Yields Insight on IEC 60601-1 3rd Edition

MET Laboratories’ product safety engineers undergo regular training to stay up-to-date with changing standards and regulatory requirements.  When possible, we will share highlights of these sessions with customers. Following are some of the key points of a recent training session on IEC 60601-1 3rd edition: It is an entirely new standard and does not match... Read More