Webinar on Demand: Innovation meets Compliance - PLM for Medical Device Development

June 10, 2014

Nordic innovation leaders in medical device development master design controls and regulatory complexity while radically cutting lead time in product development.

The key to excellence is ENOVIA PLM – embedding quality and regulatory accuracy in your daily product development work - sharing one current product definition across the extended enterprise. The webinar covers:

  • Why is ENOVIA PLM the ideal solution to meet FDA and MDD requirements – detailed mapping and demos
  • What challenges are addressed and what are the effects on lead times, cost of recalls and regulatory compliance
  • Selected applications:
    • Requirements Traceability
    • Product Development, Change Management and the DMR
    • Program, Project management and the DHF
    • QA processes embedded in product development and change management, complaints with eMDRs, CAPA, NCRs and audits
    • Environmental Requirements
  • How is the new revision of 13485 reshaping ENOVIA PLM solutions and processes
    • UDI
    • Supply Chain Integration and Risk

 

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