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 configuration-status 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.
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