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Thursday, June 08, 2017 8:22:10 AM
The remaining 2017 milestones are as follow:
Select and confirm two US and one European strategic facilities for pre-clinical studies
Test and evaluate performance of subsystems of existing engineering verification (EV) units
Complete initial formative human factors studies that follow previous heuristic studies
Initiate design changes based on subsystem performance and human factors evaluation
Implement design changes and retest system and subsystems
Update Design History File and documentation for relevant modules of the Company’s Quality Management System (“QMS”)
Complete initial requirements and architecture for simulation software and training program design
Complete and report on pre-clinical studies at strategic facilities in US and Europe
Confirm FDA and CE Mark pathways in coordination with regulatory authorities
2018 milestones:
Complete software development, system design and update Design History File for regulatory filings
Complete summative human factors evaluation
Complete simulation software development and training program design
Complete and document pre-clinical studies for FDA submittal
Prepare and submit 510(k) application to FDA and prepare Technical File for CE Mark and submit to European Notified Body
Publish white papers on pre-clinical studies
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