Are we still on track to FDA clearance — and what is at risk?
🛡 PMP Authority
Current: M+0
Overall Status
ON TRACK
Next Gate
Red Risks
0
Pending Inputs
0
Days to Next Milestone
Runway

Dual-Track Dashboard

Technical progress and regulatory milestones — side by side

🔬

Technical Track

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Regulatory Track

Gate System

Decision checkpoints — Proceed / Need Data / Stop

Risk Dashboard

ISO 14971 — Top risks, mitigation status, and residual assessment

Top 5 Risks This Week

Timeline — Business Translation

Technical milestones translated into investor and business language

Regulatory Standards Tracker

IEC 60601, ISO 10993, 21 CFR compliance matrix

Standard Description Applies To Status Progress

Cash / Runway

Financial position, burn rate, and funding milestones

China Investor API Integrations

Payment, banking, and currency APIs for Chinese investors

US-Specific API Integrations

Payment, banking, and compliance APIs for US-based investors and operations

Funding Rounds

Burn History

Action Items

Task board — assignable items with owners and due dates

DHF Document Tracker

Design History File — document status per regulatory requirement

Code Document Category Status Due

CAPA Log

Corrective & Preventive Actions tied to risk items

Budget vs. Actual

Planned spend vs. actual spend per category

Category Planned Actual Variance

Resource Allocation

Team assignments and capacity utilization

Supplier Tracker

Hardware components — lead times, PO status, milestones

Supplier Component Status Lead Time PO Status Milestone

Audit Trail

Chronological log of all dashboard actions for DHF traceability

Timestamp User Action Target Old New Detail

US Investment & Investor Relations

North America fundraising pipeline, investor tracking, and IR activities

Target Investors

Target Type Stage Contact Status Target Amount Notes

Investor Relations Activities

Change Requests

Document Control

ISO 13485–aligned document control — lifecycle tracking, revision history, and review scheduling

Category DCN Document Version Last Updated Owner Linked Status

Message Board

Threaded messaging between PMP and Dr. Dai — messages are saved locally in your browser

Posting as

Stakeholder Input