Green means the checks ran, not that the product works, so the agent assembles the evidence, lists the anomalies you are shipping knowingly, and holds the release for the person who owns it.
A build is put up for release, and for most products no law requires that any check pass first.
02
A gate turns green, and that says the checks ran, which is not the same as the product working.
Reason
03
The product is a device or an aircraft system, and the same pack becomes a controlled record.
04
An anomaly ships knowingly, and IEC 62304 clause 5.8 has it documented and each one evaluated.
05
A coverage figure is met, and stronger forms give no more insight; MC/DC is a Level A duty.
Decide
06
A suite is quarantined, and the pack says so rather than reporting a pass over what still ran.
07
An exit rule is waived, and the waiver becomes a record rather than a quiet edit to the criteria.
Out
08
A release cannot be evidenced against its own criteria, and that is recorded as the finding.
09
Execute write actions only inside the approval boundaries fixed during implementation.
→Product statement
Assembly and the pack record belong to the agent; the release belongs to a named person. FDA proposed carrying the record signature into 820.35, then deleted it in the final rule.
Example workflow
One release, evidence to decision
AgentHuman
1Evidence receivedTest results, defect records, coverage reports, waivers and the criteria in force
2Release class settledWhether nothing binds this release at all, or a quality system and a declaration of conformity do
3Pack assembled against that classThe criteria, the results against them, the residual anomalies and the gaps
4Checks appliedCriteria coverage, citation currency, waiver completeness and assembly confidence
No human action required
Stages 1 to 4 run unaided, and nothing ships at any of them — the agent is assembling, and the owner lane opens at the release gate.
5DecisionSplits at the release gate
Complete against the fixed class
Goes to the named quality owner to release.
Anything with a gap
Adds a regulatory-affairs read before that.
Owner review
The pack is held with its criteria, its residual list and the evidence each result came from.
Release · Append evidence · Send to regulatory review
Released — by the named quality owner▼
6Quality and release records updatedOnly where write access and the release-records policy allow it
7Release scoredCriteria accuracy, evidence ties, owner corrections and what regulatory review found
Quality-owner corrections
Each correction the owner makes is counted in the release evaluation.
What should not run autonomously
Human approval stays in control
Outside the boundary — human approval required8 items
Releasing a build to a market.
Deciding a residual anomaly is acceptable.
Judging which regime reaches this release.
Signing a declaration of conformity.
Automation boundaryAgent acts unaided
✓Fix the exit criteria before the evidence is read.
✓Assemble the residual-anomaly list and mark the rationales missing.
✓Hold the pack, its results and its gaps in one record.
✓Record the waiver, its justification and the approval it carries.
Nothing ships to a market except by a named quality owner, inside the agreed boundaries.
Deciding a known defect will harm nobody.
Telling a regulator the checks were adequate.
Choosing the exit criteria a release is held to.
Changes to the criteria, the pack or the record.
Example output
One release pack, annotated
This serves a quality team whose submission must give a rationale for each anomaly left unfixed; below is one release exactly as the agent leaves it.
Release pack · one candidate buildIllustrative example
Release
Recorded as
Class
Evidence of record
Confidence
Held for
Candidate build, one regulated product
Assembled against the criteria in force
Regulated, quality system
Test records, 7 August 2026
Held unreleased
The quality owner, by name
As receivedBuilt from the test records and the defect file behind them, and it claims nothing past either one.
What the pack record holdsTest recordsDefect fileWaiver register
Why no release hereDeciding that a known defect may ship is a call a named person makes.
ActionReleaseAppend evidenceSend to regulatory review
What the score decidesBelow the configured threshold a pack gets a regulatory read before the owner sees it.
Value
Where AI adds value
The same four claims, placed at the point in the workflow where each one applies.
Where the value landsValue 01 – 04
Each release assembledFrom the criterion that gates it
03Evidence
Where that evidence lands
The agent does not vouch for a check, only for what it reported and which criterion it answered; the standards behind those criteria are paywalled, so the pack cites clause numbers and quotes none.
01Approved path
Green means the checks ran
A warning letter of 23 January 2026 cited finished sensors released without accuracy testing on the finished device, under two sections reserved ten days later.
02Human review
Looked for, and not found
No section of the current Code of Federal Regulations requires a test to pass before ordinary software ships, and residual anomalies is nowhere in it; Regulation (EU) 2026/1744 defers the AI Act declaration to 2 December 2027 for Annex III and 2 August 2028 for Annex I.
04Build an evidence trail
The build, the evidence assembled for it and the person who released it stay together.
Integrations
Typical integrations
Five system groups connect to the same agent. Which of them are in scope is decided in discovery.
Test and verification systemsTest runners · result archive Planned suites and executed runs
Defect and anomaly recordsIssue tracker · anomaly file Open anomalies, by severity
Quality management recordsQMS · procedures and criteria Exit criteria and the waivers on file
Agent
Release gate assembly
Reads the evidence Assembles the pack Holds for the owner
Standards and rule libraryClause registers · rule library Clause numbers and where they stand
A programme-level correction figure can read clean while regulated first releases carry most of the rework. Nestack reports the correction rate by release class, not only across the programme.
Slice performance — reported separately, not only in aggregateIllustrative example
Slice
Failure rate
Lift
Lift vs. threshold
Status
Regulated first releases
12.1%
3.7×
Review
Cross-market submissions
8.6%
2.6×
Review
Waived exit criteria
5.4%
1.7×
Watch
Routine patch releases
2.5%
0.8×
Normal
Bar: correction-rate lift vs. routine-release baseline · scale 0–4.0× · tick marks the 2.0× review threshold2 of 4 slices over threshold
Evidence-linked improvement
What an unevaluated anomaly costs
The loop shuts when the anomaly shipped without a written evaluation is a standing case. That suite is what the next release pack is measured against.
Improvement cycle · five stagesSwitchback — the path turns at Improve and returns at Learn
01Detect
Correction rate rises on regulated first releases.
02Diagnose
The green gate that tested a part rather than the finished device, with eight hundred and sixty serious injuries and seven deaths behind it, is worked backwards until one cause is left standing.
03Improve
Every pack goes out numbered, with the evidence that filled it attached.
04Verify
Nothing ships while one touched acceptance case is still red.
05Learn
The case stays on, and the exit rules are rewritten alongside it.
Learn → DetectThe return edge. The next release pack meets a suite one case longer.
Typical build scope
Twelve workstreams across six weeks
The build scope read against the delivery timeline. Week structure follows the six-week plan — discovery, sources, gate assembly, evaluation, integration, then production validation and handover.
WorkstreamWeek 1Week 2Week 3Week 4Week 5Week 6
01Exit-criteria capture and automation-boundary work.
02Test, defect and criteria sources.
03Result-to-criterion and residual-anomaly list mapping.
04Test-result ingestion.
05Criteria, build and result binding.
06Evidence-gap scoring and review routing.
07Owner release workflow.
08Tracker and QMS integration.
09Acceptance and residual cases.
10Guardrails and release controls.
11Evidence-pack instrumentation.
12Deployment, documentation and Agent Care handover.
12 workstreams · 6 weeks · bar shows the weeks a workstream is active — several run in parallelFinal scope and sequence confirmed in discovery
Engagement tiers
What each tier includes
Rows are the capabilities named in each tier's scope. Higher tiers include everything below them.
Capability✓ in scope · — not at this tierPilotOne product, one releaseProductionProduction release workflowAdvancedMultiple products / markets
Introduced at Pilot
Pack assembly to your exit criteria✓✓✓
Named quality-owner release✓✓✓
Exit-criteria baseline✓✓✓
Introduced at Production
Reporting by build class—✓✓
Regulatory review workflow in your systems—✓✓
Approved records write-back—✓✓
Tracker-and-pipeline integration—✓✓
Introduced at Advanced
Multi-standard criteria sets——✓
Cross-release evidence packs——✓
Dense release calendars——✓
Multi-market conformity controls——✓
Build priceFrom $5,000From $8,000Custom quote
Final build priceConfirmed after discovery based on integrations, workflow complexity, evidence volume, approval controls and deployment requirements.
Separate from buildBuild pricing is separate from recurring Agent Care, which covers managed monitoring, evaluations, incidents and verified improvements after launch.
What we need from you
What you bring, and what we build with it
Each input maps to a piece of build scope and a week in the delivery timeline.
You bringWe build with it
01Your live release classes and the criteria each one is held to→Criteria capture and exit-rule versioningWeek 1
02Representative test, defect and waiver material→Evidence binding, assembly logic and the release baselineWeek 2
03Your release schedule and the owners it names→Criteria mapping, evidence binding and the automation boundaryWeek 1
04Access to the relevant runners, trackers or exports→Test, tracker and QMS assessment, then integration setupWeek 2
05Releases you would not want reconstructed→Acceptance cases and the exit roundWeek 4
06What no gate may certify→Evidence-gap scoring, review routing, guardrails and release controlsWeek 3
07A named quality owner who releases→Quality-owner sign-off, then pilot and production validationWeeks 5–6
Nothing else is requiredDeployment, documentation and Agent Care handover are ours.
Delivery timeline
Four phases across six weeks
Widths follow what a phase costs rather than the grid, so week five draws one band beneath another.
PhaseW1W2W3W4W5W6
DiscoveryW1
BuildW2 – W3
EvaluateW4 – W5
Pilot & LaunchW5 – W6
Week focusW1Criteria discovery, exit-rule versioning and the automation boundaryW2Test and tracker integration, and the exit-criteria baselineW3Assembly logic, residual-anomaly handling and release controlsW4Evaluation suite, acceptance cases and failure-mode testingW5QMS and records integration, pilot packs and targeted correctionsW6One release cycle run under the quality owner, then Agent Care handover
Reading the bandEach bar runs across the weeks its own work is named for, and week five carries two.
At the end of W6Once the release record validates, Agent Care takes the agent up.
DurationSix-week plan shown · typical delivery 4–6 weeks depending on scope confirmed in discovery.
Next step · Release gate AI agent
Build a release gate agent around the anomalies your last release shipped without a written evaluation.
Show us one release you ship on a schedule and the known defects that went out with it. If nothing beside them records why each was acceptable, that list is an inventory rather than a decision. A release nobody can evidence comes back as a finding.
