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Role of Technology in Regulatory Intelligence

  • Deciding on medical devices to develop
  • Determine which markets to bring products to and in what order
  • Determine the current and future regulatory requirements in these markets
  • Decide whether to participate in or object to planned regulations
  • Estimate efforts, durations, and costs to meet regulatory requirements
  • Ensure that the necessary staff with the required skills and competencies are in place
  • Plan and organize additional resources (service providers, tools, financial resources)