| Delivering Information Technology (IT) infrastructure within the medical device industry is a challenge for IT departments. The medical device industry has many federal and international regulatory agencies that require IT controls to be met. This project evaluates the use of the Define, Measure, Analyze, Improve, and Control (DMAIC) methodology to implement a unified quality approach to delivering IT infrastructure. The project reviews current practices and procedures for deploying IT infrastructure with quality requirements to provide evidence for a unified delivery plan. This plan identifies roles, responsibilities, and measurement requirements within the DMAIC framework. Methods are used to understand where processes can be standardized and simplified in the current process and identified in the plan. The project provides a strategy for building, implementing, and deploying IT infrastructure and ensuring compliance with any regulatory agency governing IT departments within the medical device industry. |
