P2864 - Guide for a Software Change Control System for Three-Dimensional (3D) Bioprinting of Tissue-Engineered Medical Products (TEMPs)
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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.
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