Goals:

Existing Clinical Movement Sensor Products

• Bring into compliance with FDA Design Controls regulations
• Manufacturing, Inventory and Fulfillment management

New Products

• Consumer version of Fall Detection Pendant with app that alerts loved ones
• Consumer wellness tracking device for disabled users

Roles:

• Algorithm validation testing and Design Control documentation for existing product line
• Design improvements based post-market complaint and suggestion monitoring
• Testing protocols and app design for new movement sensor applications
• Commercial packaging design and sourcing manufacturing

Results:

• LEGSys and BalanSens compliant with FDA Class I medical device registration
• Active PERS available to consumers and telehealth providers
• Disabled wellness device in prototype and early clinical trials