Configuration Management and Product Configuration in the Medical Device Industry

 

Configuration management 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.

IZiel Team would assist your team to –

  • Analyse the proposed changes to product design for determining effect on overall product and / or system.
  • Manage change orders to prepare for change authorization and documentation by company and / or subcontractor.
  • Prepare reports of change impact on overall product and product lifecycle.
  • Review and analyse released engineering change data and coordinates changes with engineering, quality, support, manufacturing, and engineering data control activities.
  • Ensure that customer requirements are implemented, and reviews change accounting activity to ensure compliance with configuration management policies.
  • Maintain functional control of product Master Data, document change control, and Quality System records.
  • Analyse and coordinate proposed changes of product design and quality system processes to determine effect on overall product and / or system, coordinating with change owners, providing feedback.
  • Review and analyse engineering change data and coordinate changes with engineering, quality, support, manufacturing, and engineering data control activities.
  • Ensure that requirements are implemented, and review change accounting activity to ensure compliance with configuration management policies.
  • Analyse and maintain data in both InfinityQS and SAP for inspection criteria and other production relevant data.


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