Robert Burek, technical expert on electrical medical device safety testing at SGS Consumer Testing Services, held a presentation at the International Medical Standards Update seminar, hosted by the International Trade Assistance Center (ITAC) and the Manufacturing Advocacy and Growth Network (MAGNET) on March 24, 2011 in Cleveland, Ohio.
Understanding the latest standards
The seminar was designed to help executive level management, engineering professionals, compliance executives, legal departments, and environmental and medical professionals to better understand and comply with recent changes to standards and directives on medical device safety. These changes will alter testing strategies for many device manufacturers. The presentation at the all-day event included discussions on the IEC 60601-1 3rd Edition standard governing medical device safety as well as risk management under ISO 14971.
Robert Burek is an assessor for the IECEE CB Scheme (http://www.us.sgs.com/sgssites/ee/rohs-iecee_usee.htm) and is a member of the IECEE Expert Task Force for medical, laboratory, audio and information technology equipment and the US TAG for TC 62 (IEC 60601). The seminar was organized by the Northeast Ohio Trade & Economic Consortium.
Find out more about SGS Medical Device Testing Services (http://www.ee.sgs.com/e-e-medical-device-testing-ee.htm) or contact us:
SGS Consumer Testing Services
Robert Burek
Global Medical Device Technical Manager
SGS North America, Inc., 291 Fairfield Avenue, Fairfield NJ 07004, USA
t: +1 (404) 275 1134
E-mail: cts.media@sgs.com
Website: www.sgs.com/ee
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