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