Configuration Management in the Medical Device Industry

1. Configuration Management in the Medical Device Industry Configuration management is “a process for establishing and maintaining the consistency of a product’s performance, functional and physical attributes with its requirements, design and operational information throughout its life.” It is imperative to develop product configurations and manage them effectively. A structured configuration management program ensures accurate and consistent product documentation (e.g., requirements, design, test, and acceptance documentation) along with the actual physical design of the product. Configuration Management plays an important role to ensure thorough product variations to enhance customer satisfaction, competitiveness, profitability & continuous changes/requirements. Therefore, it’s critical that the product and process configuration is unified across the organization, which minimizes handoffs of specialised information. Configuration Management must include – 1. Enterprise or Unified Supply Chain Configuration Solution 2. Error-Proofing 3. Intuitive and Flexible IZiel has highly trained configuration managers who will be able to create, coordinate and implement the Configuration Management Plan (CMP – includes responsibilities and resources, (including personnel), training requirements, administrative meeting guidelines (including a definition of procedures and tools), baselining processes, configuration control and configuration-status accounting, naming conventions, audits and reviews, subcontractor/vendor configuration

2. management requirements, regulatory requirements) for Product Creation Process (PCP) projects in co-operation with the Project Managers and Operations Department.