Therapeutic and Diagnostic Device Outcomes Research

Book Cover - Therapeutic and Diagnostic Device"Therapeutic and Diagnostic Device Outcomes Research" is an outcomes research primer for those in the therapeutic and diagnostic device field with the purpose to inform:

- Health outcomes researchers on the unique characteristics of therapeutic and diagnostic devices, and

- Medical device developers and researchers on the basic principles of clinical, economic, and patient-reported outcomes research for therapeutic and diagnostic devices

Table of Contents

  • Part 1:   Introduction
  • Part 2:   Research and Development
  • Part 3:   Regulatory Requirements in USA and Europe
  • Part 4:   Clinical Outcomes Research
  • Part 5:   Therapeutic Device Clinical Outcomes Research
  • Part 6:   Diagnostic Device Clinical Outcomes Research
  • Part 7:   Drug-Device Combination Research
  • Part 8:   Economic Evaluations
  • Part 9:   Patient-Reported Outcomes Research
  • Part 10: Evidence Development and Reimbursement

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