FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

NEMA Issues New QMS Standard for Servicing Imaging Equipment

April 16, 2019

The National Electrical Manufacturers Association (NEMA) released a new quality management standard for servicing medical imaging equipment—designed to ensure equipment is returned to a safe and effective condition for its intended use.

The voluntary standard was originally conceived as an ANSI standard. NEMA and its Medical Imaging and Technology Alliance (MITA) division plan on continuing to work with industry stakeholders to develop an ANSI standard, but released the voluntary standard now “to protect patients and device integrity.”

The standard is applicable to any medical imaging equipment servicing organization, regardless of its size or the specific equipment maintenance services it provides. It includes definitions for complaints, intended use, objective evidence, validation, verification, planned maintenance, quality management systems, remanufacture, rework and repair, among others.

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