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Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
This session is designed to inform the attendees about the FDA’s proposed rule to amend the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) Regulation to align more closely with the international consensus standard for Quality Management Systems for medical devices used by many other regulatory authorities around the world.
The FDA proposes to do so primarily by incorporating by reference the 2016 edition of the international standard specific for medical device quality management systems set by the International Organization for Standardization (ISO), ISO 13485. Through this rulemaking, the FDA is also proposing additional requirements that help connect and align ISO 13485 with existing requirements in the Federal Food, Drug, and Cosmetic Act and its implementing regulations, and make conforming edits to 21 CFR Part 4 to clarify the device CGMP requirements for combination products.
Oriented primarily towards medical device professionals, those engaged in the following functions will derive great benefit from attending.
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MD and Vice President, MEDIcept Inc.
Kim is an expert in Medical Device, InVitro Diagnostics, and Combination Products. She brings over 30 years of experience in the field, spanning her work at the US FDA for over 24 years, as well as working with Regulatory Agencies around the globe. With a demonstrated history of working collaboratively with industry, regulators, and patient groups for the betterment of public health her perspectives are comprehensive and pragmatic at the same time.
She has also been engaged in (a) writing and harmonizing the current 1996 US FDA Quality System Regulation and was on the international authoring group of ISO 13485 since inception in 1994, and, a twenty year veteran of the Global Harmonization Tasks Force (GHTF) and foundational member of the International Medical Device Regulators Forum (IMDRF).
Kim earned her Master's Degree in Biomedical Engineering from University of Virginia, and has won awards as FDA Engineer of the Year, and for Distinguished Service from the US Department of Health and Human Services.
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