Work Headlines

Concepts

  • Initial Study and Options

Engineering – Mechanical & Electronics (Hardware & Software)

  • 3D Solidworks Design. (& Electronics Design) (& Components Sourcing)
  • Modeling Stage Technologies
  • Industrial Design (In collaboration with External vendors)
  • Material & Components Selection
  • Mass Production Technologies & Vendors Selection (Complete DMR)

Trials (Animal/Cadavers/Human)

  • Animals – Ex Vivo / In Vivo / Acute / Chronic
  • Cadaver – Various sites
  • Human – Safety & In Service

Regulations (In collaboration with a Regulatory Affairs and Quality Assurance consultancy firm)

  • DHF, DMR, DHR
  • Risk Analysis
  • Specifications, Work Instructions, Bench Testing, Packaging
  • Labs & V&V
  • Sterilization Technologies

Intellectual Property (In collaboration with an IP firm)

  • Preparation of the technical material