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IDE Software Handoff Memo

Status: Internal handoff memo Owner: BionicLoop engineering Last updated: 2026-04-07 12:32 EDT

Purpose

Give the receiving quality/submission team a short handoff note for the current IDE software packet.

Current Position

The software packet is ready for review.

Formal freeze actions remain open.

What is ready now:

  • a concise reviewer-facing packet in this folder
  • explicit scope/defer decisions for the current software handoff
  • proportionate study-facing risk and cybersecurity summaries
  • a clear boundary between engineering-owned software deliverables and downstream quality/submission ownership
  • an RTM audit summary showing what still requires formal promotion

Included Review Packet

Candidate FDA-Facing Content

These are the documents to start with for external software review:

Internal coordination materials such as this memo, the freeze disposition memo, the RTM audit summary, the formal evidence execution plan, and the freeze command sheets are not intended as the primary external review set.

Explicit Deferred Or Non-Owned Items

  • cloud / device-to-cloud verification closure
  • Part 11 package closure
  • SRS-SEC-003..009 auth/provider/session continuity closure
  • step-0 BG rescue (SRS-BG-008 / TV-BG-007)
  • formal review/approval signatures
  • final IDE submission assembly and release authorization

Open Actions Before Freeze

  1. fill the final baseline freeze SHA
  2. execute/promote formal evidence for the claimed subset
  3. execute/promote TV-SEC-001
  4. record the receiving-team disposition on the documented investigational export/file-sharing posture using IDE_Receiving_Team_Freeze_Disposition_Memo.md

Recommendation To Receiving Team

Use this packet as the primary review package.

Use the larger /Users/jcostik/BionicLoop/Docs/Quality/ library only as background/support material unless additional scope is intentionally added to the IDE baseline.