Active PAR

P2864

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

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
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Status
Active PAR
PAR Approval
2020-03-05

Working Group Details

Society
IEEE Engineering in Medicine and Biology Society
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Sponsor Committee
EMB/Stds Com - Standards Committee
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Working Group
3D-B TEMPs - Three-Dimensional (3D) Bioprinting of Tissue-Engineered Medical Products (TEMPs)
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IEEE Program Manager
Tom Thompson
Contact
Working Group Chair
Lexi Garcia
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No Active Standards
No Superseded Standards
No Inactive-Withdrawn Standards
No Inactive-Reserved Standards
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