One of the key items that need to be resolved before a project can go through a complete translation for a medical device is to know the marking and labeling requirements of the devices, the user manuals, the screen prompts, and the packaging. One key aspect of marking and labeling requirements comes from IEC 60601-1, the standard for medical electrical devices. IEC 60601-1 has gone through a major paradigm change in the way medical electrical devices are evaluated.
Along with the change in paradigm are some new and modified requirements and test methods for the marking and labeling of these devices. This audio conference will highlight changes to marking and labeling requirements from the second to the third edition.
How to Mark & Label Devices Under IEC60601-1 3rd Edition is presented by Leo Eisner, Product Safety & Regulatory Consultant, of Eisner Safety Consultants. For more details on this audio conference, please visit our site www.fxconferences.com
