All medical device 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 Minneapolis, Minn. and San Diego, Calif. areas learn about and plan for the new edition of the Standard, TÜV Rheinland is hosting a seminar, “Transitioning to IEC 60601-1 3rd Edition” in these locations. Individuals involved in regulatory affairs and compliance are encouraged to attend.
The event will take place in Minneapolis, Minn. on Monday, May 7, from 9 a.m. – 4 p.m. at the Minneapolis Marriott West. The seminar will take place in San Diego, Calif. on Wednesday, June 6, from 9 a.m. – 4 p.m. at the Marriott Courtyard San Diego Sorrento Mesa/La Jolla.
The presenter is Dale Hallerberg, Technical Manager for Medical Product Testing at TÜV Rheinland, who was 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 manufacturers can benefit from starting the transition to the 3rd Edition early, to allow for advanced planning for compliance of medical device testing, as well as to reduce the risk associated with the new requirements. Attendees will also learn about 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 help plan for a smooth transition
Cost to attend is $500 per person and group rates are available. To register or learn more, go to http://education.tuv.com/iec-60601-1-3rd-edition-seminars. Groups of five and larger should email firstname.lastname@example.org.
Posted by Janine E. Mooney, Editor
April 16, 2012