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