Late last month, the Medical Imaging & Technology Alliance (MITA) announced that it is expanding the scope of the NEMA American National Standard for Servicing of Medical Imaging Devices to cover all medical devices, not just medical imaging technologies. This decision comes after the consideration of extensive stakeholder feedback indicating a desire for one, universal standard for the medical device industry.
The voluntary, consensus-based NEMA Standard will outline the minimum quality management system requirements for medical device servicing. When followed, the standard will ensure servicers consider operational, performance and safety factors to ensure safe and effective device operation.
“With an expanded scope, MITA will now leverage its existing consensus across various stakeholder groups to codify what quality management of medical device servicing should look like for the industry,” said MITA Executive Director Patrick Hope. “Given the many perspectives on this issue, MITA is committed to an open and balanced development process.”
Interested stakeholders, including manufacturers, independent servicing organizations, clinical engineers, health care providers, regulators, accreditors and others are welcome to apply by May 11, 2018.
For an application or more information, contact MITA Director of Policy and Strategy Peter Weems at email@example.com.