This document provides guidelines for how to develop and implement a software change control system to manage all changes made during three-dimensional (3D) printing of medical products to create tissues or tissue-like structures (bioprinting) for transplantation into an animal or human, and/or anatomic modeling purposes. The change control system will provide a process to ensure that the changes made to the product are introduced in a controlled manner.
- Sponsor Committee
- EMB/Stds Com - Standards Committee
Learn More - Status
- Active PAR
- PAR Approval
- 2020-03-05
Working Group Details
- Society
- IEEE Engineering in Medicine and Biology Society
Learn More - Sponsor Committee
- EMB/Stds Com - Standards Committee
Learn More - Working Group
-
3D-B TEMPs - Three-Dimensional (3D) Bioprinting of Tissue-Engineered Medical Products (TEMPs)
Learn More - IEEE Program Manager
- Tom Thompson
Contact - Working Group Chair
- Lexi Garcia
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