Scottcare TeleRehab II Cardio Monitoring System

Scottcare 2/25/98 TeleRehab II Cardiopulmonary Monitoring System

Failure to maintain a complete Device History Record (DHR) in that it does not contain updates to software or their location, or document rework and evaluation of non-conforming finished devices or part.

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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