Audio Conference

How to Mark & Label Devices Under IEC60601-1 3rd Edition Leo Eisner Product Safety & Regulatory Consultant Eisner Safety Consultants Purchase recording US$199

Purchase a recording of this Audio Conference

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.

This audio conference will address:

• The new and modified test requirements for marking and labeling per 3rd edition
• Summary of the differences between 2nd and 3rd edition marking and labeling requirements
• The importance of using a marking and labeling review document to support your risk management file
• A useful guide in Annex of IEC 60601-1

Speaker biography:

Leo Eisner is the head of Eisner Safety Consultants, specializing in helping medical device, IVD and high-tech device clients navigate international product safety and regulatory processes such as the FDA 510(k), CE marking and the Canadian Medical Device Regulations. He is a registered Professional Engineer in the Safety Engineering discipline, with over 20 years of experience in product safety. He worked at UL for nine years in a wide variety of product categories, then spent several years with TÜV Product Service, specializing in electrical medical products. He later joined Karl Storz Imaging as a Compliance Engineer, and has been consulting independently for the past nine years. Leo has co-authored numerous articles on IEC 60601-1 and medical device safety. He is a member of several IEC 62 technical advisory groups for the IEC 60601 series of standards and is the convener of IEC SC62D JWG9 (IEC 60601-2-58). He is also a member of RAPS, AAMI, ASQ & IEEE.

Who Should Attend?

• Compliance engineers
• Product safety engineers
• Regulatory affairs
• Technical writers
• R&D engineers
• Engineering managers
  
  This audio conference is rated General Interest.
  

Purchase Options:

• Purchase a recording of this event US$199