Complaint & MDR intake
Reads the inbound complaint, classifies it against device and lot history, drafts the initial record, and flags the cases that may be reportable for human review.
All industriesAI for medical
[ Primary beachhead · Medical Devices & Diagnostics ]
AI for medical
devices and diagnostics.
Scale complaint intake, regulatory knowledge, field and clinical support, quality signals, and commercialization without scaling manual coordination at the same rate. We connect the work across the QMS and tools your team already uses, so the operating layer grows with the installed base — and stays inside your controls.
Best for Device & diagnostics makersSweet spot $10M – $500MTeam size 50 – 1,000Lead-in Workflow audit
[ What we hear ]
The same six
bottlenecks, in every stack.
The device is different, the regulatory class is different, the shape of the friction is not. These are the workflows where agentic systems compound fastest.
- Complaint volume scales faster than the quality team can hire
- The same regulatory and IFU questions surface week after week
- Field and lab inquiries drain hours from specialists who should be on accounts
- Quality signals surface only after the trend has already formed
- Service and CAPA cases lose their audit trail across systems and people
- Cleared claims take a week to turn into the next compliant campaign
[ Workflows ]
Six workflows
that earn their keep.
Each one has clear ownership, repeatable patterns, and measurable outcomes — the three ingredients agentic systems need to earn their keep.
Regulatory & quality knowledge
Grounded on your QMS, design history files, IFUs, and submission records — answers questions consistently and stays current as documents and revisions change.
Field & clinical support
Triages field and lab inquiries, drafts responses with the right clinical and technical context, and routes escalations to the specialist before the second message.
Quality signal visibility
Watches complaint trends and nonconformance signals, flags anomalies, surfaces CAPA candidates, and warns before a field issue becomes a pattern.
Service & installed base
Structures service intake, applies the right warranty and maintenance policy, drafts the field reply, and routes the case for dispatch — without losing the trail.
Commercial & content ops
Repurposes cleared product claims and clinical evidence, drafts launch sequences, and keeps messaging consistent and compliant across channels at the volume growth requires.
[ Sample agentic ecosystem ]
A coordinated team
around the device lifecycle.
Seven agents covering complaint intake, regulatory knowledge, field support, quality signals, service, commercialization, and executive reporting — coordinated, supervised, measured.
- 01Complaint intake agent
- 02Regulatory knowledge agent
- 03Field support agent
- 04Quality signal analyst agent
- 05Service workflow agent
- 06Commercial content agent
- 07Executive brief agent
Built for the QMS, the field, and the systems behind both
Pick the workflow
eating your team this quarter.
A workflow audit returns a prioritized opportunity map and a build proposal — whether or not you build with us.