A 45 page 483 for the American Red Cross Biomedical Headquarters. Many of the observations are computer-related although it is not always clear if the issues are with medical devices, validation, or Blood Establishment procedures and use error.
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.
