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MITA Eyes 2017 as Pivotal for Medical Imaging

MITA Eyes 2017 as Pivotal for Medical Imaging

This piece was originally published in the February 2017 issue of electroindustry. Joe Robinson, Senior Vice President of Health Systems Solutions, Philips Healthcare, and Chairman, MITA Board of Directors The Medical Imaging & Technology Alliance (MITA) is well-positioned to lead efforts that will leave a positive and lasting impact on the medical imaging technology industry. MITA’s 2017 strategic priorities reflect these opportunities: Permanently repeal medical device tax The 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 […]

Standardizing the Value of Quality

Standardizing the Value of Quality

This piece was originally published in the November 2016 issue of electroindustry. Jim Nestel, Manager Service Projects and Installations, Hitachi Medical Systems Only original equipment manufacturer (OEM) service providers are required by the Food and Drug Administration (FDA) to have a quality management system (QMS) to assess medical imaging equipment. Although many non-OEM medical imaging device service providers perform excellent work, the lack of such a requirement leaves the 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 […]

Understanding Symbols: Laser Labeling

Understanding Symbols: Laser Labeling

By Geoffrey Peckham, CEO, Clarion Safety Systems One of the critical building blocks for your product safety labels is symbols. When it comes to the history and progress of formats and symbols related to labels on laser products, manufacturers face a dilemma in using U.S. regulations versus internationally accepted standards. In this article, we’ll explore laser labels compliant with the Center for Devices and Radiological Health (CDRH) for U.S. markets and the International Electrotechnical Read more […]