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IndustriesMedical Devices & Regulated Manufacturing

AI Agents That Speak QSR —
Built for FDA-Regulated Manufacturing

We come from electronics and medical-device contract manufacturing under FDA Quality System Regulation (21 CFR 820). We know the documentation burden, the audit pressure, and the thin margins. We build AI agents that take on the manual, compliance-heavy work — without putting your quality system at risk.

Start a 2-Week Agent PilotBook a Discovery Call
20+ years delivering enterprise programs$7M+ programs managed250+ resource transformationsDeep FDA/QSR-regulated experienceBuilt on Anthropic Claude
Why this industry
is different

In regulated manufacturing, almost every process generates a record — and every record can be audited. CAPAs, nonconformances, device history records, supplier qualifications, complaint files: the documentation is relentless, the standards are unforgiving, and the people doing it are too valuable to spend their days on formatting and chasing signatures. Generic automation can't touch this work safely. We build agents that do — inside your quality system, with full traceability.

Highest-impact agents

Where teams see value fastest. Three agents most clients start with — pulled from the deeper map below.

01Flagship agent

CAPA & NCR Backlog Reduction

CAPAs and NCRs eat hours of manual write-up. An agent drafts them, routes them for review, and tracks each to closure — so engineers review and approve instead of starting from a blank page.

See the full role map
02Flagship agent

Supplier Qualification & Audit-Prep

Qualifying a supplier means assembling a thick packet by hand. An agent gathers the documentation, flags what's missing, and assembles the audit packet — so the team walks in prepared.

See the full role map
03Flagship agent

RFQ & Quote-Response Acceleration

In thin-margin manufacturing, RFQ turnaround directly affects win rate. An agent accelerates quote-response prep — so the team responds faster and wins more of the work that drives revenue.

See the full role map
Where agents create value

By department and role

Our agents don't replace your people — they take the manual load off them. Each one handles the repetitive, documentation-heavy work so your specialists spend their time on judgment, exceptions, and the calls only a human should make.

The departments we know, the roles inside them, and the manual work an agent can take on. We build to your actual processes after discovery — this is a map of where the highest-impact opportunities tend to live.

5 departments · 9 roles
Department I

Quality & Regulatory Affairs

01
CAPAs and NCRs eat hours of manual write-up. An agent drafts them from your inputs, routes them for review, and tracks each to closure — so engineers review and approve instead of starting from a blank page.
02
Incomplete records stall the whole workflow. An agent pre-screens quality records for missing fields and signatures before they enter the formal process — so nothing bounces back later.
03
Systemic issues hide across dozens of separate records. An agent summarizes trends across NCRs and complaints — so engineers spot patterns weeks earlier.
01
Submission packages take days to assemble and cross-check. An agent gathers the documentation and checks it against current FDA and ISO requirements — so specialists spend their time on judgment, not collation.
02
A single inconsistency can sink a filing. An agent flags gaps and contradictions across regulatory documents before submission — so problems surface early, not in a deficiency letter.
03
Regulatory changes are easy to miss. An agent monitors and summarizes updates relevant to your device classes — so the team stays current without manual tracking.
01
Chasing approvals is a full-time distraction. An agent routes documents for review, follows up on overdue signatures, and flags bottlenecks — so releases don't stall on a missing initial.
02
Controlled documents fail audits over small format errors. An agent checks each for version, format, and required-field compliance before release — so the document set stays audit-ready.
03
Reconstructing a paper trail under audit pressure is painful. An agent maintains complete, traceable document trails automatically — so the history is always there when an auditor asks.
Department II

Manufacturing & Operations

01
Work instructions go stale and rewriting them is tedious. An agent drafts and updates process documentation from engineering inputs — so engineers keep instructions current without the busywork.
02
Deviations between as-built and the device master record are easy to overlook. An agent compares the two and flags discrepancies — so issues are caught before they reach the floor.
03
Line and yield data sits unread in spreadsheets. An agent summarizes performance for review — so engineers act on the numbers instead of compiling them.
01
A batch can't ship until its DHR is complete, and checking by hand is slow. An agent pre-checks device history records for completeness before release — so batches don't sit waiting on a manual review.
02
Shift summaries get written from memory at the end of a long day. An agent generates them from raw line data — so handoffs are accurate and instant.
03
Deviations bounce between people before reaching the right owner. An agent triages and routes them automatically — so they get resolved faster.
Department III

Supply Chain & Procurement

01
Qualifying a supplier means assembling a thick packet by hand. An agent gathers the qualification documentation and flags what's missing — so engineers chase gaps instead of building the file from scratch.
02
Incoming certificates and records pile up unreviewed. An agent pre-screens supplier records and certificates of conformance — so problems are caught at receipt, not in production.
03
Supplier audits start cold every time. An agent assembles the audit packet and surfaces prior findings — so the team walks in prepared.
01
RFQ intake is slow and manual. An agent extracts requirements and drafts structured quote requests — so buyers move faster on every quote.
02
Comparing quotes line by line is error-prone. An agent compares supplier quotes against requirements and historical pricing — so buyers negotiate from a clear picture.
03
Purchase documentation waits on manual drafting. An agent drafts and routes it for approval — so procurement keeps moving.
Department IV

Sales & Business Development

01
In thin-margin manufacturing, RFQ turnaround directly affects win rate. An agent accelerates quote-response prep — so the team responds faster and wins more of the work that drives revenue.
02
Customer responses require pulling scattered technical and capability data. An agent assembles it into customer-ready answers — so engineers respond in hours, not days.
03
Proposals start from scratch every time. An agent drafts a first pass from intake details — so the team refines instead of writing cold.
Department V

Complaint Handling & Post-Market

01
Complaint intake and classification is manual and time-sensitive. An agent intakes and classifies complaints and routes reportable events to the right workflow — so nothing reportable slips through.
02
Investigation files start empty. An agent drafts complaint records and pre-fills investigation templates — so specialists begin from a working draft.
03
Single complaints obscure bigger trends. An agent surfaces patterns that may signal a systemic issue — so emerging problems get caught early.
How we keep it compliant

Compliance built in, not bolted on

Every agent we build respects your quality system. We assess data-retention and vendor policies up front, build full audit trails into every agent action, keep a human in the loop wherever your process and regulations require it, and monitor agent usage so nothing operates outside your controls.

Compliance built in, not bolted on.

Start small, prove it fast

Pick one process. Prove it in two weeks.

A CAPA backlog, supplier qualification, RFQ turnaround. In two weeks, for a fixed fee, we'll build a working agent proof-of-concept around it, complete with a feasibility, ROI, and compliance assessment. If you move forward, the pilot fee credits toward your full build.

Start a 2-Week Agent PilotBook a Discovery Call
2 Weeks Fixed fee · Fixed timeline

Pilot candidates we see most

  • CAPA & NCR backlog reduction
  • Supplier qualification & audit-prep automation
  • RFQ & quote-response acceleration
  • DHR completeness checks before release