P30 · Issue 01 · 2026  ·  Built for the regulated.
Available for new engagements · Q3 2026

Ruthless efficiency.
Not pedantic compliance.

Protocol30 is an AI-driven regulatory operations partner for medical device companies. We implement and manage your quality and regulatory organization at a fraction of the cost of a full-time VP, with the same executive judgment, and a faster, leaner operating model.

At a glance
~30yrs
Executive QA/RA experience
6–12wk
To audit-ready QMS
20–30%
Of a full-time VP's cost
10max
Active clients at any time
Serving
Class I & II Devices SaMD & Digital Health IVD & Diagnostics Combination Products Connected Devices Drug Delivery Seed through Series B
01 · The Problem
What every growing device company faces.

You built this company to develop a device.
Not to become an expert in 21 CFR 820.

A · Duct-taped

SOPs that don't connect to your actual workflows.

A QMS that was assembled for the first 510(k) and hasn't been touched since. It looks compliant on paper. It doesn't survive an audit.

B · Undercapacity

Junior staff doing their best without senior guidance.

A QA manager is not a VP of Quality. The judgment that makes the difference between a clearance and an RTA only comes from hundreds of submissions.

C · Moving target

Enforcement patterns shift faster than the regulations.

QMSR is here. AI-enabled devices are accelerating submissions. You need someone who lives in this world, not a binder from a consultant who already moved on.

D · Investor exposure

Diligence questions you can't answer in a deck.

"What's your regulatory strategy? What does your quality system look like? Who owns it?" Three questions that decide your next round.

02 · The Math
A side-by-side of what regulatory leadership actually costs.

The real cost of regulatory leadership.

Dimension Option A · Full-time VP of QA/RA Option B · Protocol30
Annual costTotal comp, fully loaded $350K – $450K+Plus benefits, equity, recruiter fees $96K – $300KAll-in retainer · scoped to stage
Time to engagementFrom decision to in-seat 3 – 6 monthsSearch · interviews · onboarding ~2 weeksDiscovery → scope → kickoff
AI integrationWorkflow compression UnlikelyTooling decisions deferred to staff Built inDrafting · review · monitoring · governance
Continuity riskIf the person leaves System walks outRe-hire and rebuild from scratch System staysYour eQMS, your SOPs, your IP
CapacityOutput ceiling One personSingle point of judgment and failure AI-multipliedOne expert + agentic workflows = team output
Δ · Annualized savings: Up to $354K redirected to engineering and clinical.
03 · The Engagement
Two phases. One outcome: a system that works.

We don't deliver binders. We build a functioning system, and we stay on to run it.

Phase I
Architect.
A fixed-scope, fixed-fee build. We assess your current state, design a QMS that fits your device and pathway, and stand it up in a modern eQMS, with AI workflows wired in from day one.
Gap analysis · QMSR readinessWk 1–2
eQMS configurationWk 2–4
SOP & document controlWk 3–6
Risk + design controlsWk 5–8
AI workflow integrationWk 6–10
Training & handoffWk 10–12
Timeline · 6–12 wk
Fee · Fixed
Phase II
Navigator.
Ongoing fractional executive management. Senior oversight on CAPA, submissions, supplier quality, and FDA interactions, with continuous monitoring of standards and enforcement shifts.
Fractional VP of QA/RAOngoing
510(k) / De Novo / eSTARAs-needed
CAPA & management reviewMonthly
Supplier qualityQuarterly
Audit prep · FDA interactionsOn-call
Team mentorshipContinuous
Tier · 3 levels
Cadence · Monthly
Or start here
QMSR Readiness Assessment
$5–8K · 2–3 weeks · Gap analysis with prioritized remediation roadmap. The QMSR transition is live — have you completed your gap analysis?
04 · The Force Multiplier
A new work paradigm. One expert. AI as leverage. No headcount ceiling.

AI doesn't replace the expert.
It multiplies what the expert can do.

The old model
More work requires more people.
Compliance workload scales with headcount. Each new device, each new submission, each new audit cycle means another hire. Quality departments grow linearly with the portfolio. The cost compounds. The org chart expands. And when someone leaves, knowledge walks out the door.
→ 1 device = 1 QA/RA hire
→ 3 devices = 3–4 FTEs + overhead
→ Knowledge walks out when people do
The Protocol30 model
Workload scales. Headcount doesn't.
AI-assisted workflows handle the throughput that used to require teams: drafting SOPs, researching predicates, redlining submissions, monitoring enforcement changes. One expert with the right AI stack delivers what previously required four generalists — and does it faster, with better judgment applied at every step.
→ 1 expert + AI = team-level output
→ Portfolio grows — headcount stays flat
→ Knowledge is in the system, not the person
How the force multiplier works in practice
01 · Draft
AI writes the first pass
SOPs, submission sections, risk analyses, design control documents — drafted in minutes, not days.
02 · Review
Expert applies judgment
Nearly 30 years of pattern recognition applied to every AI output. No document leaves without senior sign-off.
03 · Monitor
AI watches the landscape
Enforcement trends, new guidance, standard updates — continuously tracked so nothing catches the client off guard.
04 · Scale
System grows, not headcount
New device? New submission? New indication? The QMS infrastructure handles it. No additional hire required.
"This is a fundamentally different work paradigm. AI has created the efficiency multiplier that makes fractional executive management viable at scale — one expert can now manage what previously required a department."
Ben Kimball · Founder, Protocol30
10×
Faster drafting
~70%
Lower cost
05 · The Math, Restated
Why one expert plus AI outperforms five generalists with spreadsheets.

One expert. Agentic workflows. Team-level throughput.

Traditional Stack
VP of QA/RA$420K
QA Manager$180K
RA Specialist$140K
Doc Controller$95K
Spreadsheets · Email · Word∞ hrs
Protocol30 Stack
Senior judgment · Ben Kimball~30 yrs
Drafting agent10× faster
Predicate research agentdays → mins
Review & redline agentalways-on
Modern eQMS · Greenlight Gurusingle source
Output: Same throughput. ~70% lower cost. Better judgment per artifact. Audit-ready by design.
06 · The Differentiation
What anchors every engagement.

Three pillars. Every engagement. Every artifact.

01 · Risk
For Founders + Boards
Mitigation by design.
A QMS built right from the start eliminates the regulatory surprises that derail launches and unsettle investors. Surprise is removed before it becomes a problem.
FOR · Founders + boards
02 · AI
For Engineering + RA
Integration, not bolt-on.
Agentic AI compresses the workflows that used to take weeks: submission drafting, document review, predicate research, risk analysis. AI handles throughput. We provide judgment.
FOR · Engineering + RA
03 · Scale
For CFOs + Acquirers
Yours to keep.
Your QMS grows as you do: first 510(k), commercial launch, post-market. The system we build is yours. If you outgrow the fractional model, you keep everything.
FOR · CFOs + acquirers
B
Benjamin Kimball
Founder, Protocol30
~30
Years QA/RA
Exec
Level
Founder
Benjamin Kimball · ~30 years QA/RA executive · Medical devices
"A quality system should produce safe products. Passing audits is how you can tell it's working — not why you build it."
Ben Kimball · Founder, Protocol30
07 · Start here
Let's talk about your regulatory roadmap.

A 30-minute discussion about where your quality and regulatory program stands and where it needs to go. If Protocol30 is the right fit, we'll scope a path forward. If it isn't, we'll tell you that too.

1 · Discovery call
30 minutes
No pitch, no pressure. We listen, you decide.
2 · QMSR assessment
$5–8K · 2–3 wks
Gap analysis with prioritized roadmap.
3 · Phase I proposal
Fixed scope + fee
If we're a fit, the build begins.