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Phase II ActiveNIH / NINDSLead Product Engineer
COT
Cognitive Optimization Therapy — Disease-Modifying Alzheimer's Intervention
End-to-end hardware lifecycle for an Alzheimer's disease-modifying intervention device with full ISO 13485 / IEC 62304 compliance and usability engineering per IEC 62366.
$3.13MR44NS125745
Project Facts
- Role
- Lead Product Engineer
- Phase
- Phase II
- Status
- Active Development
- Funding
- $3.13M
- Grant Number
- R44NS125745
- Agency
- NIH / NINDS
NIH Award History
$500KPhase I2022
1R44NS125745-01A1
$1.35MPhase II2024
4R44NS125745-02
$1.28MPhase II2025
5R44NS125745-03
Engineering Challenges
- Managing end-to-end hardware lifecycle from concept through manufacturing scale-up
- Integrating multi-system validation protocols across hardware and software components
- Building IEC 62366 usability engineering files alongside active device development
- Coordinating NINDS regulatory strategy with ongoing clinical-trial execution
- Ensuring ISO 13485 QMS continuity across multiple hardware generation transitions
Technology Domains
Hardware Lifecycle ManagementISO 13485IEC 62304IEC 62366FDA Design ControlsSystem Validation