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Tag: medical devices

Setting a Global Priority: Test Once, Sell Everywhere

Setting a Global Priority: Test Once, Sell Everywhere

This piece was originally published in the November 2016 issue of electroindustry. Hans Beinke, Chair, MITA Global Affairs Committee Just as MITA works with Congress and the U.S. Food and Drug Administration to improve regulatory and business conditions, its Global Affairs Committee (GAC) works with partners in an increasingly interconnected world to streamline regulatory procedures and strengthen members’ businesses. When threats to global business emerge or countries enact barriers Read more […]

Focusing on Regulatory Environment

Focusing on Regulatory Environment

This piece was originally published in the November 2016 issue of electroindustry. Diane Wurzburger, Executive, Regulatory Affairs, GE Healthcare MITA’s Technical and Regulatory Committee (TRC) promotes a regulatory environment that supports growth and innovation in medical imaging. In 2016, the TRC set three priorities: successful Medical Device User Fee Amendments (MDUFA) negotiations; critical to quality (CtQ) engagement, which is part of a of the U.S. Food and Drug Administration Read more […]

Regulatory Challenges Emerge for Additive Manufacturing

Regulatory Challenges Emerge for Additive Manufacturing

This piece was originally published in the August 2016 issue of electroindustry. Megan A. Hayes, Director, Regulatory and Standards Strategy, MITA Additive manufacturing (AM) is another term for the synthesis of three-dimensional objects—otherwise known as 3D printing. This concept is nothing new to the U.S. Food and Drug Administration (FDA), which already has approved or cleared more than 80 medical devices and one prescription drug that are manufactured using 3D printing processes. On Read more […]