Issues

[SC 7] Draft "Training Plan for Tidepool Loop for Users and HCPs" summary for inclusion in 510(k)
REG-93
Draft iCGM Sensitivity Analysis Methods and Results Summary
REG-92
Draft Post-Market Study Plan
REG-91
Create Tidepool Loop Full Demo Video
REG-90
Draft Tidepool Loop Maintenance Plan
REG-89
Draft Patient Testimonial Summary
REG-88
Complete/Consolidate 510(k) Body Master Document
REG-87
Observational Study Adverse Event Summary and Reports
REG-86
White paper on Guardrails and warnings based on data analysis from the Jaeb Observational Study
REG-85
Draft Jaeb Data Safety Analysis - Tidepool Loop Settings, Related Mitigations
REG-84
[To Do] Generate Submission Check-list from Meeting Minutes and Written Feedback from All FDA Q-Subs
REG-83
Documentation of Requirements iAGC Special Controls
REG-82
iCGM and ACE Pump Functionality Accessible from within Tidepool Loop
REG-81
[To Do] Determine whether and how to include Patient Preference Information (PPI) documentation in support of Submission
REG-80
[Section 16.j] Output of open bugs in Jira
REG-79
[Section 16.i] Output of Github Releases Page for Tidepool Loop
REG-78
[Section 16.d] Create Architecture Design Charts
REG-77
[Section 16.c, e, f] Draft Summary of how Tidepool has documented "requirements" "specifications" and established traceability
REG-76
[Section 16.h] Draft Summary of Verification and Validation Outputs
REG-75
[To Do] Confirm Traceability of all Requirements, Hazards, Mitigations, Verification, and Validation (Jira Review)
REG-74
[Section 16] Draft Statement of Major Level of Concern
REG-73
[Section 18] Draft Summary of Bench Testing
REG-72
[Section 07] Draft Statement of Non-Class III Device
REG-71
[SC 5/6] Documentation of Tidepool Loop Restricting Compatibility to only iCGMs, ACE Pumps, and other devices deemed appropriate by FDA
REG-70
[SC 4] Documentation of Measures to Record Critical Events
REG-69
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