10xAnd
Scoping review

V&V 10x

Verification testing without the bottleneck.

Automated fixtures, AI-drafted protocols and reports formatted to your SOP, and a named engineer signing off on every method call — in one fixed-price package.

Send me the one-pager Request a scoping review
10X-SVC-VERIFY REV B
What
Verification Readiness Scan
Price
Fixed, quoted in 48 h
When
1 week to deliverable

AI-drafted · evidence-cited · human-reviewed

Why this holds up

01

Test automation is the day job, not a side skill

The alliance is staffed by engineers who have designed verification fixtures and executed protocols on Class II and Class III programs.

02

Your SOP, your templates, our drafting speed

Protocols and reports are generated into your document templates, not ours. Method selection and sample-size rationale are drafted by AI against the applicable standard, then reviewed and signed by a named engineer before anything reaches you.

03

Closed loop from fixture to report

Instrumented fixtures write structured data files that feed the draft report directly. The transcription step between the bench and the document — the step that generates data-integrity findings — is removed.

How it works

  1. VER-01

    Send the inputs

    Requirements or design-input list, current test plan or protocol drafts, and your protocol and report templates. Under NDA before anything moves.

  2. VER-02

    Scan and score

    Every requirement is mapped to a verification method, an acceptance criterion, and a sample-size rationale. Gaps, untestable requirements, and unjustified criteria are scored by risk to the schedule.

  3. VER-03

    Engineer review

    A named engineer reviews every AI-drafted method call and rationale, corrects it, and signs the review record. Findings you disagree with are marked as such rather than removed.

  4. VER-04

    Readout

    A one-hour walkthrough of the scored gap table, the recommended test plan, and what it would take to execute it — with us, or with your own bench.

What the work looks like

The verification pipeline A requirement selects a test method; the method drives an instrumented fixture; the fixture writes a structured data file; the data file populates a draft report; a named engineer reviews and signs, and the signed report returns to the requirement to close the trace. The method, data file, and draft report stages are automated; the engineer review is a human gate on them. AUTOMATED Requirement REQ-014 Method + sample size Fixture instrumented Data file structured Draft report to your SOP Engineer review named · signed Signed report trace closed closes trace human gate
FIG. 1 The verification path, with the segments this pilot automates highlighted. Human review is a gate on the automated segments, not a rubber stamp after them.

The tool behind this line

TestForge

Design preview

Closes the verification loop: plan, protocols, fixture data and report as one chain, with a human review gate before anything ships.

A rendered preview of the intended interface. Not running software.

A preview of TestForge. It frames verification as four jobs — two writing, two execution — then shows a closed loop of eight nodes and one gate: design inputs, verification plan, draft protocols, automated fixture, results file, draft report, human review, signed package. A verification plan matrix lists requirements with test method, sample size, size rationale and acceptance criteria, marked planned values with nothing measured. The review gate blocks the signed package until a named reviewer dispositions every item, then turns green and the loop closes with the review record inside the package.

Watch it run 1:08

A rendered preview. The video says it out loud in its second line: nothing here is a working system yet.

No audio track · every line is captioned on screen · nothing is fetched until you press play

Transcript (12 lines)
  1. 0:00 Verification is four jobs. Two are writing. Two are execution.
  2. 0:08 Nothing here is a working system yet.
  3. 0:14 Four jobs, one loop, and one step a machine never takes.
  4. 0:19 The writing collapses first: the plan, then the protocols.
  5. 0:25 Method, sample size, why that size, acceptance criteria.
  6. 0:33 Automation runs the units. The rig writes the data.
  7. 0:40 It lands in the draft report untouched.
  8. 0:47 The loop stops here, on purpose.
  9. 0:50 A red-flag list marks what is never decided alone.
  10. 0:56 No named reviewer, no signed package.
  11. 0:59 Someone signs every item. The gate turns green.
  12. 1:03 The loop closes. The review record ships in the package.

Edited before publishing: Final line trimmed from the recording.

A TestForge verification plan matrix with four requirements. Each row carries a test method — tensile pull to separation, leak by pressure decay, torque to failure, cycle durability — a sample size, the rationale for that size such as 95/90 attribute, an acceptance criterion, and a protocol number. The panel is headed PLANNED VALUES, NOTHING MEASURED.
Every sample size ships with the reason for that sample size. The header states plainly that nothing here has been measured.
The TestForge review stage, showing the point where the loop deliberately stops and a red-flag list marks the items that are never decided by the tool alone, with the signed package withheld until a named reviewer dispositions each one.
The loop stops here on purpose. A red-flag list marks what a machine never decides alone.

TOOL-03 Concept preview — nothing shown here is a working system yet, and the capture says so in its own chrome. The matrix carries planned values, not measurements.

The offer

The pilot engagement

This is a new service line and we are pricing it to learn: a fixed fee, quoted within 48 hours of the scoping review.

Intake is limited. We run a small number of scans concurrently so the engineer who signs your method calls is the one who made them. If the scope is larger than one device and one requirements set, we say so at the review rather than after.

One device, one requirements set, one week from kickoff to readout.

The same closed loop extends to end-of-line inspection: machine-vision final test that runs on hardware inside your building, with the TMV documentation that makes the station audit-ready.

What you receive

  • A scored verification gap table: every requirement mapped to method, acceptance criterion, sample-size rationale, and a risk score for the gap.
  • A recommended test plan you can execute yourself, including fixture requirements and which methods are candidates for automation.
  • A standards-reference sheet naming the clauses and methods each recommendation rests on.
  • The human-review record (below), and a one-hour readout call.

What the human-review record contains

  • The named engineer who reviewed each section, and the date.
  • Every AI-drafted item that was corrected, with the correction.
  • The standard, clause, or method reference relied on for each method call.
  • Open questions we could not resolve from the inputs supplied.
Get the one-pager Request a scoping review
10X-SVC-VERIFY REV B
What
Verification Readiness Scan
Price
Fixed, quoted in 48 h
When
1 week to deliverable

AI-drafted · evidence-cited · human-reviewed

Limited intake

Get the Verification Readiness Scan one-pager

Scope, deliverable, and what we need from you at kickoff. One page, no gate beyond your address.

This reaches us as an email and we reply to it — we are not adding you to a mailing list, because we do not run one yet. See the privacy policy.

Questions we get

Which standards does the scan cover?

It covers the verification methods applicable to your requirements, which for most device programs means a mix of consensus standards and internal methods. Biocompatibility requirements are mapped against the ISO 10993 series, electrically active devices against the applicable IEC 60601 clauses, and mechanical requirements against ASTM or ISO methods where one exists. Where no consensus method applies, the scan says so and proposes an internal method with a written rationale rather than inventing a reference.

What exactly is in the deliverable?

A scored gap table covering every requirement in the list you send, a recommended test plan, a standards-reference sheet, and the human-review record. It is a document you can hand to your own test engineer and act on. It is not a protocol package — protocol drafting is the next engagement, priced separately.

Do we have to use your fixtures?

No. The scan tells you which methods are automation candidates and what a fixture would need to do; whether that fixture is ours, yours, or a contract lab’s is your call and does not change the price of the scan.

How do you justify sample sizes?

Sample-size rationale is drafted from the acceptance criterion, the requirement’s risk classification, and the statistical basis your quality system already accepts — attribute or variable, reliability and confidence targets, and whether the requirement is safety-related. Every rationale is reviewed and signed by a named engineer, and every one states its assumptions so your reviewer can disagree with the assumption rather than the number.

How is AI used, and how do you keep it out of the record?

AI drafts: it proposes method calls, acceptance criteria, and rationale text against the standards and your templates. It does not decide. A named engineer reviews every item before delivery, and the review record shows what was corrected. Your documents and data are not used to train any model, and are processed under the confidentiality terms in the SOW.

Can this extend to final / end-of-line inspection?

Yes, and it is the same closed loop one station further down the line. Machine-vision final inspection — including neural-network classifiers where the defect is easier to show than to specify — runs on hardware installed inside your building, so production images and models stay on your site and never leave it. That matters for IP and it removes a whole class of data-transfer questions from your quality agreement. The deliverable includes the test-method validation package: method description, the image and defect set used, acceptance criteria, repeatability and reproducibility results, and the human-review record, formatted so document control can file it. We describe what the station is built to do and how it was validated; we do not publish detection-rate claims, because those belong to your validated configuration and your product, not to a marketing page.

What if the scan finds our plan is fine?

Then the deliverable says so, and you have a defensible record that says so. We would rather hand you a short gap table than manufacture findings to justify the fee.

Other ways we 10x device programs