BionicLoop Documentation Portal

Last updated: 2026-02-11 21:55:00 UTC

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.

Start Here (Clinical + Quality)

1. Quality Overview
2. Risk Analysis (RA)
3. Software Requirements Specification (SRS)
4. Software Design Description (SDD)
5. Software Verification and Validation Plan (SVVP)
6. Requirements Traceability Matrix (RTM)
7. Evidence Index

Current Operations

• Active execution and delivery planning: Execution Plan
• Active defect tracking: Bug Tracker
• Security planning: Cybersecurity Plan
• Development process: Development SOP

Technical References

• System architecture: Architecture
• App visual language: Design System
• 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.

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.