Peabody, Massachusetts. TÜV SÜD America is pleased to announce that they will present at MD&M West 2013. The show takes place from February 12-14, 2013 in Anaheim, California. MD&M West 2013 is the world's largest medtech design and manufacturing event, featuring the latest industry trends, and advancements in medical technology. The company will also exhibit during the event at booth #1852.
Mr. Uwe Degenhardt, Division Manager for Active Medical Devices, will deliver a presentation on "Updates/Implementation of IEC 60601-1 3rd Edition: Electrical testing (FDA consensus standard)." This presentation will take place on Wednesday, February 13, 2013 at 10:20 a.m. in room 213C, and will discuss an overview of the 3rd edition and Amendment 1, understanding some significant changes in amendment 1 to IEC 60601-1 3rd edition, and how to transition to IEC 60601 in a timely manner.
Mr. Degenhardt's second presentation titled, "Fast track to CE Marking: Strategies for timely compliance and commercialization," will occur on Thursday, February 14, 2013 at 3:10 p.m. in room 213B. Some of the topics covered in this presentation will include how to identify the practical steps for achieving CE Marking, understanding the requirements of conformity assessment specific to the device governed by the relevant EU Directive, and working with the Notified Body to meet all requirements for conformity assessments.
Mr. Degenhardt is a certified Lead Auditor for ISO13485 and the Medical Device Directive MDD93/42/EEC, with over 15 years of experience. He is authorized under the FDA 510k Third-Party Approved program and also for Canadian Medical Device Regulations. He received a Masters Degree in Biomedical Engineering from the Technical University of Dresden in Germany, and spent six years testing medical devices at TÜV SÜD Product Service GMBH before transferring to TÜV SÜD America.
For more information on TÜV SÜD America’s medical services, visit TÜV SÜD during MD&M West at booth #1852, and enter our raffle for your chance to win an iPad, or visit http://www.tuvamerica.com/medical.
For more information, contact:
Division Manager- MHS
TÜV SÜD America Inc.
For editorial information, contact:
Marketing Communications Specialist
TÜV SÜD America Inc.
About TÜV SÜD Group
TÜV SÜD is a major international service group operating in the INDUSTRY, MOBILITY, and CERTIFICATION business segments. With more than 17,000 staff, we are represented at over 800 locations worldwide. Our teams of specialists are engaged in optimizing technology, systems, and know-how, and thus act as process partners, enhancing the competitive strength of our customers throughout the world.
About TÜV SÜD America Inc.
TÜV SÜD America Inc., a subsidiary of TÜV SÜD AG, is a leading globally recognized testing and certification organization. TÜV SÜD's Product Service Division offers international safety testing and certification services. With more than 1,200 experts in North America, TÜV SÜD America provides NRTL and SCC Certification, CB Scheme Certification, Field Evaluations, SEMI Evaluations, and other Industrial Machinery Services. Additional services include Restricted Substances, CE Marking assistance, International Compliance, EMC/Environmental Testing, and Quality Management System Certification. TÜV SÜD also provides CE Marking assistance for the European market, Electromagnetic Compatibility (EMC), Electrical & Mechanical testing, and many additional global conformity assessment services that help companies gain product compliance in order to enter individual country markets. For more information, visit www.TUVamerica.com.
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