What is configuration management and why is it important?
Configuration management for medical device is a system engineering process for establishing consistency of a product’s attributes throughout its life.Configuration management for medical device is a system engineering process for establishing and maintaining consistency of a product’s performance, functional and physical attributes with its requirements, design, and operational information throughout its lifecycle. The configuration management process facilitates orderly management of product information and changes for purposes as to revise capability, improve performance, reliability, or maintainability, extend life, reduce cost, reduce risk and liability or correct defects.
Configuration Management for medical device must include –
Enterprise or Unified Supply Chain Configuration Solution Error-Proofing 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 configurationstatus accounting, naming conventions, audits and reviews, subcontractor / vendor configuration management requirements, regulatory requirements) for Product Creation Process (PCP) projects in co-operation with the Project Managers and Operations Department.