BionicLoop Documentation Portal

Last updated: 2026-04-05 13:15 ET

This portal is the shared documentation surface for engineering and clinical collaboration.

Clinical and safety review should start in the Quality document chain.

Safety Note

This project is investigational software and is not for human use.

Canonical Risk Source

Use Docs/Quality/RiskAnalysis.md as the single risk-register source. Docs/Requirements/RiskAnalysis.md is an alias pointer only, and the prior narrative is archived in Docs/Requirements/RiskAnalysis_LegacyNarrative.md.

Start Here (Clinical + Quality)

1. Quality Overview
2. Risk Analysis (RA)
3. Software Requirements Specification (SRS)
4. Software Design Description (SDD)
5. Alert Inventory and Mapping
6. Software Verification and Validation Plan (SVVP)
7. Requirements Traceability Matrix (RTM)
8. Evidence Index
9. Code Review Log
10. Instructions for Use (IFU) v1.4

Current Operations

• Active execution and delivery planning: Execution Plan
• Current offline basal review packet: Dash Offline Basal Fallback Feasibility Review
• Current meeting packet: March 20, 2026 IDE Readiness Briefing
• Current sprint operator checklist: Next Sprint Checklist
• Telemetry cloud contract and backend handoff: Telemetry Cloud Integration Plan, Telemetry Contract for BionicScout
• Medium-fidelity simulation harness plan: Medium-Fidelity Harness Plan
• Algo2015 verification planning and phase tracker: Algo2015 Verification Plan, Algo2015 Execution Roadmap
• Active defect tracking: Bug Tracker
• Security planning: Cybersecurity Plan
• Development process: Development SOP

Technical References

• System architecture: Architecture
• App visual language: Design System
• Cloud environment setup: Cloud Environment Strategy
• Protocol baseline notes: Protocol
• Marjorie comparison analysis: Marjorie Algorithm I/O Gap Analysis
• OmniBLE integration reference: OmniBLE API

Clinical Collaboration Workflow

When proposing or reviewing a change:

1. Confirm risk impact in Risk Analysis.
2. Confirm requirement impact in SRS.
3. Confirm design impact in SDD.
4. Confirm verification plan/evidence path in SVVP and RTM.
5. Capture defects and evidence in Bug Tracker and Evidence.
6. Record code-review outcomes and fixes in Code Review Log.

Directory Map

• Architecture/: system and UI architecture references.
• Analysis/: comparative analysis and implementation gap studies.
• Integrations/: package and device integration references.
• Planning/: execution backlog, implementation planning, and brainstorm docs.
• Protocol/: protocol source artifacts.
• Quality/: primary regulated-quality and traceability documentation set.
• Requirements/: product/study requirement working docs.
• Setup/: developer and TestFlight setup/onboarding docs.