CAPA & investigations
$54,087
labor recovered / year
Modelled value
What does this look like in dollars?
Four levers, all yours to edit: hours your team gets back, consultant scope you stop buying, revenue from earlier market entry, and audit-readiness on every record. Replace the defaults with your numbers; the output is your math.
Your team
Used by every labor lane below.
$
At a US standard 2,080 hours/year, this is $72/hr.
Complaints & MDR
$28,846
labor recovered / year
NCR, change, risk, gap, SOP
$23,077
labor recovered / year
Document control & training
At 20% time on doc hunt (McKinsey baseline).
$120,000
labor recovered / year
Regulatory submissions
510(k), De Novo, registration renewals.
$
$
Your number. Default $0 - calculator does not surface a revenue claim you did not enter.
$125,000
annual value (labor + consultant + revenue)
- Internal labor saved$45,000
- Consultant cost reduced$80,000
- Revenue acceleration$0
Post-market surveillance + AI drift
$23,077
labor recovered / year
Risk-adjusted
Expected-value dollars, kept separate from realised labor so the math stays auditable.
Default catch rate 25%, default WL cost $1,000,000.
$50,000
WL avoidance / year (risk-adjusted)
Total modelled annual value
$424,087
Modelled, not measured. Pilots include a baseline so this moves from modelled to measured.
How the math works
Labor recovered
records/yr × hrs/record × cut% × hourlyFive domains run on the same formula: CAPA, Complaints & MDR, Records, Doc control, PMS. Hours that went to hunting and stitching go to review and signature.
Submissions value
labor + consultant + revenue510(k) and De Novo drafts cut internal labor and consultant scope. Revenue acceleration is your number - default $0 so we never surface a claim you did not enter.
Audit-readiness (risk-adjusted)
(WLs/yr) × catch rate × remediation $Not a promise of zero findings - your QMS and your team do that. What Deminn does is cite every claim and surface every gap before closure, so the records are defensible when the auditor shows up. Kept separate from realised dollars.
What Deminn does and does not promise.
Does: cite every claim, flag every gap, draft records in a defensible shape, and give your team back the hours that went to hunting and stitching. Does not: replace your QMS or guarantee an FDA outcome - those stay yours. Pilots are in flight; catch-rate and first-draft-cut defaults are conservative estimates grounded in the system’s design, not customer data. Modelled numbers get replaced with measured ones as pilots ship.
Bring your numbers to a pilot conversation.
Founder-led setup with a baseline measurement, so the modelled dollars become measured ones.