Regulatory Compliance

FDA Cleared Software Products

The FDA designated blood bank software a regulated medical device in 1994. BBCS embraced the new regulations, implemented all Code of Federal Regulations (CFRs) within our standard operating procedures ensuring all Design Controls (FDA 21 CFR 820.30) were ingrained in our software development process, and began remanufacturing our software to meet the new FDA regulations.

The Blood Bank Control System in its entirety (both the donor and patient modules) was 510(k) cleared by the FDA on October 15, 1997 under the following number: BK960044. Subsequent BBCS product releases have also been given FDA clearance:

ABO Suite


  • BBCS Hospital (HL7) Interface, Version 1.0.0 510(k) cleared #BK090081
  • BBCS BloodTrack Interface, Version 1.0.0 510(k) cleared #BK120028

Blood Bank Control System

  • BBCS Primary Application 5.0P 510(k) cleared #BK040056
  • BBCS Mobile Application 5.0M 510(k) cleared #BK050013
  • BBCS Lab Application 5.0L 510(k) cleared #BK040087
  • BBCS Primary Application 5.4.3 510(k) cleared #BK140142

Not only has BBCS become expert in developing software for medical devices, we also make sure our clients have the tools and user documentation needed to support implementation of our software. We include Risk Mitigation Guides and a Management Guide to Implementation with every release, which provides a checklist during implementation ensuring compliance every step of the way.

BBCS thoroughly understands the regulated healthcare world, adapts to changes in the industry, and ensures our software is in compliance—to the benefit of our clients.