The Servicing of Medical Devices: In Need of Repair, Regulation, or Redemption?

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Long-simmering tensions over the supportability of healthcare technology are bubbling up big time this year, triggered by a Food and Drug Administration (FDA) initiative to scrutinize postmarket activities and, in particular, the provision of third-party services.

Whether this initiative turns out to be a tempest in a teapot or a harbinger of new rules or standards is anybody's guess. Regardless, it certainly has touched a nerve for a broad set of interest groups, including manufacturers, third-party service providers, and healthcare technology management (HTM) professionals in healthcare systems and hospitals.

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