Oracle Agile PLM (A9)

Solution for medical devices

 

 

The requirements imposed on the development of medical devices are similar to those for high-tech electronics. However, the development and modification of medical devices is also subject to compliance with the specifications and regulations of the US Food and Drug Administration (FDA), the regulatory and supervisory authority for these areas.

Typical FDA requirements for medical devices

  • Data and process management for development, change and quality assurance
  • Central repository for product data, documents and structures (DHF and DMR)
  • Multi-level BOMs for components, with document references
  • Requirements and monitoring of compliance with regulations and standards
  • Portfolio, project and cost management

 

  • Secure collaboration between internal and external partners and customers
  • Quality management for CAPA guidelines and FDA regulations, monitoring
  • Optimized processes for innovation, development, placing on the market and change
  • Digital signature (FDA Title 21 CFR Part 11)
  • Audit management, documentation and validation
  • Collaboration and visualization with AutoVue

Oracle Agile PLM A9 modules

  • Product Collaboration
  • Portfolio Management
  • Engineering Collaboration (CAD integration)
  • Product Governance and Compliance
  • Quality Management
  • Cost Management
  • AutoVue Enterprise Visualization
  • Product Lifecycle Analytics
Interested in finding out more?
Contact us!
Tel. +49 7244 947-100

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