The change stems from stakeholder feedback indicating a desire for one universal standard for the medical device industry, according to MITA.
The new standard is voluntary and will outline the minimum quality management system requirements for medical device servicing. When followed, the standard will ensure that servicers consider operational, performance, and safety factors to provide safe and effective device operation, MITA said.
Interested stakeholders -- such as manufacturers, independent servicing organizations, clinical engineers, healthcare providers, regulators, and accreditors -- may apply by May 11. For an application or more information, contact MITA Director of Policy and Strategy Peter Weems at email@example.com.
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