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/
Find out more about SGS Medical Device Testing Services (http://www.ee.sgs.com/
SGS Consumer Testing Services
Global Medical Device Technical Manager
SGS North America, Inc., 291 Fairfield Avenue, Fairfield NJ 07004, USA
t: +1 (404) 275 1134
SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With 64,000 employees, SGS operates a network of over 1,250 offices and laboratories around the world.