Get up to speed on the latest requirements incorporated into the 3rd Edition of IEC 60601-1 and take the guesswork out of marking and labeling your medical devices!

Marking and labeling is just one area to tackle in the complicated development of medical devices, but it is a critical one to understand. How do you make sense of all those regulations? It’s challenging enough preparing and testing the device; then you have to worry about the user manuals, screen prompts and packaging too.

In this audio conference, Leo Eisner guides you through each new, added or modified regulation incorporated into the most recent revision of IEC 60601-1. The third edition of this cornerstone standard for medical electrical devices sees major changes from the second edition, changes you need to know about for successful compliance. Ease your marking and labeling stress with detailed guidance from a leading expert.

This audio conference covers:

• How risk management relates to labeling and marking
• New testing requirements under IEC 60601-1 3rd edition
• The important document you need for “proof of compliance”

About the speaker:

Leo Eisner leads Eisner Safety Consultants (www.eisnersafety.com) in its efforts to help medical device, IVD and high-tech device clients navigate international product safety compliance, regulatory processes such as the FDA 510(k), CE marking and the Canadian Medical Device Regulations, and quality systems such as internal auditing and setting up quality systems.

As a registered Professional Engineer in the Safety Engineering discipline, he has over 24 years experience in product safety. In his nine years with UL, he worked with a variety of product categories and 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 10 years. He has also been a notified body auditor for TÜV Product Service and is currently auditing for NSAI.

Leo is a member of RAPS, AAMI, ASQ and IEEE and has co-authored numerous articles on IEC 60601-1 and medical device safety. His most current article on IEC 60601-1 3rd edition is titled Regulatory Strategies for the Third Edition of IEC 60601-1, published Sept 2009, and can be viewed at www.eisnersafety.com/safety_articles. He is the convener of IEC SC 62D JWG9 (IEC 60601-2-58) and is a member of several IEC 62 technical advisory groups for the IEC 60601 series of standards.

Who should attend?

• Product safety engineers
• Regulatory affairs
• Technical writers
• R&D engineers

This audio conference is classified as General Interest.

ForeignExchange Translations provides specialized French-Canadian translation services to medical device and pharmaceutical companies.