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Purchase a recording of this Audio Conference The IEC 60601 3rd Edition represents a major change in the way medical devices are evaluated and approved. This audio conference will provide an overview of the major differences between the 2nd and 3rd Editions of the standard, including process changes for assessing acceptable risk, in addition to the electrical and mechanical changes. Because the changes have a major impact on the way certification is viewed, there is still a lot of discussion among the major medical markets on how to interpret the standard, what national differences to include, and what requirements will be required to assess conformity. We will also provide an update on the adoption status in the major medical device markets. This audio conference will cover:
About the speaker: Casey Conry is a Senior Project Engineer for Underwriters Laboratories working out of UL's Chelmsford, MA office. He has worked as a Product Safety Engineer since 1998, evaluating numerous types of medical devices from infusion pumps to X-ray systems to patient monitors. He is an accredited FDA 510(k) 3rd Party Reviewer under FDA's Accredited Persons Program and has reviewed numerous 510(k) submissions for various types of medical devices. He has specialized experience and knowledge in US/Canadian Certification and the FDA 510(k) processes. Who should attend?
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