Medical Information Tech Blood Bank Software

Medical Information Technology 3/6/97 Blood Bank Software Manufacturer

c. Quality Assurance audits do not cover any quality assurance activities associated with the software customization program.

4. Failure to establish an adequate complaint handling program for the [purged text] as required by 21 CFR 820.198 in that complaints are not reviewed by a formally designated unit and complaints which relate to a possible hazard to safety are not kept in a separate portion of the complaint file.

5. Failure to establish an adequate personnel training system as required by 21 CFR 820.25 in that there is not documentation of training and personnel are not aware of the GMP and MDR regulatory requirements under which your firm is required to operate.

6. Failure to assure that the device specification changes are subject to controls as stringent as those applied to the original design, as required by 21 CFR 820.100, in that software defects were identified by users rather than identified during your software validation activities. Examples of these defects include such significant software elements as donor antibody history, ([purged text]) and donor blood type ([purged text]).

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.

62304 Software Training Course – February 23-25, 2021

IEC 62304 and Emerging Standards and FDA Expectations for Medical Device and Health IT Software – Virtual

This very popular 3-day course provides a clear understanding of applying IEC 62304 standard for medical device software and much more. The course compares and contrasts 62304 with FDA expectations and discusses approaches for alignment. In addition, participants will learn of other relevant standards and technical reports pertinent to medical device software, HealthIT, medical mobile apps, and Software as a Medical Device (SaMD) products (e.g., 82304, 80002-1, 14971, 80001-2-x, 62366).

Participants will gain practical advice and pragmatic experience with all types of medical software. Participants will leave with a clear understanding of how to effectively and efficiently integrate 62304 compliance into their software development lifecycle (SDLC).

Register (click):  EventZilla Registration Site

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