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The Nuances of Medical Device Trials

  • Use of Advertising/Social Media
  • Inclusion/Exclusion Criteria
  • Assisting Site Coordinators
  • Orphan Drugs/Special Populations
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The Nuances of Medical Device Trials

  • 510(k)/PMA-505(b)/NDA
  • Predicate Devices
  • IVD's and Sample Management
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Commonly Overlooked Product Development Issues

  • Clinical Medicine vs Protocol Medicine
  • Phase II vs Phase III Considerations
  • "Non-Drug Studies"
  • Investigator Meetings and Team Training
  • Protocol Waivers
  • Global Studies
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