MCD Analysis Introduction

Throughout the years, regardless of the type of industry decision making and decision situation especially, healthcare and management remain the most critical requirements to safeguard the risks to users are as minimized as possible before launching the device into the market. While medical device manufacturers for instance, utilizes the current available risk tools to predict the future fit, form and functionality of a device at design stages and during the manufacturing process, it remains a difficult accomplishment to take away all potential present risks for improving the successful device launch and reducing the consequences of risks.

This software presents several applications and extensions for multiple criteria decision making know as (MCDM) methods known in the industry, but not so much in the medical device manufacturing, to justify for such input variables. Most importantly, this software presents the user with different MCDM applications based on what the goal of the comparison analysis is. The outcome of this software highlights the more sophisticated methods such as Analytical Hierarchy Process (AHP), Risk Priority Number (RPN), and other important tools within the software. Most importantly, the software provides the user with a detailed analysis regarding Process Failure Mode and Effect Analysis (PFMEA) in comparison with other methods that is widely used in the medical device manufacturing.

The workload in the software is based on research and thirty years of experience in Quality and regulatory and other aspects of life that require decision making of which eighteen years in the medical device quality, regulatory and compliance. The software was developed to provide the user with specific known industry methods to assess risk and multi criteria decision making in over thirty modules and categories that can be found in the software. In addition, the user is provided with a full technique focusing on the pros and cons of using the Process Failure Mode and Effect Analysis (PFMEA) in assessing risk of medical devices. Lastly, a model is available for the user to input the goal, the criteria, sub-criteria, sub sub-criteria and finally the alternatives.