Piedmont Hospital Inc.

Company: Piedmont Hospital Inc.
Product: Blood and blood components
Date: 8/3/04

On March 7, 2004, a technician entered compatibility test results for two blood units (_____ #_____) into the blood bank computer system as compatible. However, the actual test results were not obtained from ARC (who performed the compatibility testing) and there were no compatibility test records at your facility to support the results that were entered in the computer by your blood bank technician.

FDA District: Atlanta District Office

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.

SoftwareCPR Training Courses:

IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TX) and Canada.