Course Highlights
  • Development lifecycle
  • Multi-phase development approach
  • Discovery, engineering + verification
  • Human-centered design specifications
  • Usability research
  • Risk mitigation, minmize user error
  • Verification + validation testing concepts
  • Multi-phase development approach [continued]
  • Pilots
  • Post-market surveillance
  • "Laws" of the MedTech world
  • Key regulatory concerns and requirements
  • FDA submission requirements
  • FDA quality requirements navigation
  • FDA systems navigation
  • How to avoid costly pitfalls
  • Various types of clinical trials
  • How to plan and manage clinical trials
  • How to partner with clinical research organizations [CROs].
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NEMIC: MedTech Product Development

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