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Regulations in Medical Devices Industry to Take Effect in 2012

Tue, 12/13/2011 - 12:00pm
Posted by Janine E. Mooney, Editor

All medical manufacturers must comply with the updated IEC 60601-1 standard, or the 3rd Edition, establishing new requirements for the safety and effectiveness of medical equipment. The standard will take effect in June 2012 in Europe and Canada and in June 2013 in the United States. Failure to implement the requirement can result in delaying the product to market and lost revenue.

To help manufacturers in the Santa Clara, Calif., area learn about and comply with the new standard, TÜV Rheinland is hosting a seminar “Transitioning to IEC 60601-1 3rd Edition.” The presenter is Dale Hallerberg, Technical Manager for Medical Product Testing at TÜV Rheinland, who was a part of the IEC 60601-1 development team. Hallerberg holds a bachelor’s of science degree in Electrical Engineering from the University of Illinois in Champaign, Ill. He has more than 25 years of experience in product safety testing and electrical safety research and is a member of the Association for the Advancement of Medical Instrumentation Electrical Section.

Hallerberg will discuss how manufactures can benefit from transitioning early to the 3rd Edition, ensuring product compliance with standards worldwide and reducing the risk of company liability by meeting approved safety standards. Attendees will also learn the following:

o Changes to the IEC 60601-1
o Reasons behind the changes
o Impact to the business from a manufacturing and design standpoint
o Actions, steps and deadlines to ensure a smooth transition

Individuals involved in regulatory affairs and compliance, research and development, imports and exports, sales and product marketing are encouraged to attend.

TÜV Rheinland’s “Transitioning to IEC 60601-1 3rd Edition” event will take place on Monday, January 16, 2012, from 9 a.m. – 4 p.m. at the Biltmore Hotel and Suites in Santa Clara, Calif. Cost to attend is $500 per person and group rates are available.

To register or learn more, go to http://app.myemailfx.com/t/ViewEmail/y/97885A488EA6DEF4

December 13, 2011

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