Tag Archives: Application of Risk Management to Medical Devices

FAQ: Risk Management for IEC 60601-1

Medical

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

IEC 60601-1 3rd Edition for Medical Electrical Equipment Continues to Gain Adoption in Global Markets

Medical, Product Safety

The 3rd edition of IEC 60601, issued in 2005, is in various states of adoption by regulatory bodies around the world.  IEC 60601-1 is the harmonized standard for medical electrical equipment recognized by public health authorities in most countries.  Unlike 2nd edition, the 3rd edition requires a risk management file and process conforming to ISO... Read More