Lee Memorial Hospital Blood Bank

You have also failed to establish written procedures for all operations being performed by your blood bank. No written procedures are established for registering donors electronically, registering donors manually on your mobile unit, maintaining your donor base and searching for duplicate and/or unsuitable donors on a set schedule, review of donor suitability records to assure completeness prior to release of blood products for transfusion or your HCV lookback process.

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.

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

Interested in having a conversation?  Email us to arrange a Zoom meeting or call us at +1 781-721-2921.

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