Medical Devices
Cut complaint review time. Ship documentation faster. Protect margins as volume grows.
Your team should not be losing hours every week chasing complaint details, searching controlled documents, rebuilding sales reports, or drafting the same regulatory and commercial responses from scratch.
MVP.dev builds AI automation systems for medical device companies that plug into the tools you already use, including Greenlight Guru, MasterControl, Arena PLM, Propel, ETQ Reliance, Veeva Vault QMS, TrackWise, Salesforce, HubSpot, NetSuite, SAP, Microsoft Dynamics 365, ServiceMax, Zendesk, Jira, and Smartsheet.
We help device teams reduce manual review, speed up complaint routing, retrieve controlled knowledge faster, improve sales follow-up, and give quality, regulatory, and commercial leaders better visibility.
Production-ready in 3 to 4 weeks.
Get a Workflow Fit Assessment See the Medical Devices Automation DemosBuilt for device teams that are growing faster than their back office can support
This is for medical device manufacturers, distributors, contract manufacturers, diagnostic device companies, digital health hardware teams, and post-market support teams that already have demand but are stuck behind manual quality, regulatory, sales, and support workflows.
You are likely a strong fit if:
- Complaint intake still depends on inboxes, spreadsheets, and manual routing
- Quality, regulatory, and field teams waste time searching SOPs, IFUs, DHF files, CAPAs, and prior responses
- RFPs, tenders, distributor packets, and clinical value summaries take too long to prepare
- Leadership dashboards are rebuilt manually from CRM, ERP, QMS, and service exports
- Your team uses Greenlight Guru, MasterControl, Arena, Veeva, Salesforce, NetSuite, SAP, or a similar device stack
- You want systems that plug into your current workflow, not a disruptive software migration
If your company is growing but quality, regulatory, support, and sales operations still depend on manual review, manual routing, and manual reporting, there is almost certainly margin and capacity trapped inside the workflow.
The fastest wins we usually find
Complaint intake and escalation routing
A complaint that sits in the wrong inbox for two days is not just an admin problem. It is a compliance and customer-risk problem.
We build complaint intake workflows that classify incoming issues, extract product, lot, patient, site, and failure details, check for missing information, route likely reportable events for review, and create a clean handoff for quality or regulatory teams.
The goal is simple:
- Complaints routed to the right queue faster
- Missing details requested early
- Potential MDR or vigilance items flagged for review
- Every intake decision logged
For many teams, this can reduce complaint triage time by 20 to 30 percent and recover 6 to 12 hours a week from manual intake review, depending on complaint volume and current routing rules.
See the Complaint Routing Demo →Controlled document answers without document hunting
Quality and regulatory teams lose too much time searching across SOPs, IFUs, DHFs, risk files, validation reports, and prior submissions.
We build cited-answer systems that let approved users ask plain-English questions and get answers grounded in controlled documents, procedures, work instructions, product specs, complaint history, and selected regulatory references.
Every answer includes a source trail so the team can verify it before using it.
- No blind answers
- No unsupported claims
- Jump-to-source citations
- Role-aware access to sensitive documents
This can turn 20-minute document searches into 2-minute lookups and reduce repeated interruptions for quality, regulatory, engineering, and support leads.
See the Controlled Knowledge Demo →RFP, tender, and distributor packet drafts
Sales teams lose momentum when every hospital RFP, distributor request, or value-analysis packet starts from a blank document.
We build research-to-response workflows that pull from approved product language, clinical evidence summaries, reimbursement notes, regulatory status, technical specs, and prior responses to generate a first draft for human review.
Your team gets a usable starting point:
- Personalized cover letter or executive summary
- Draft response sections from approved sources
- Product and compliance language kept consistent
- Reviewer checklist before anything is sent
A response package that used to take 4 to 8 hours to draft can often be reduced to 60 to 90 minutes of review and editing, while keeping final approval with your team.
See the RFP Builder Demo →Executive visibility across sales, quality, service, and inventory
Leadership should not need four exports and a Friday spreadsheet session to know what is slowing growth.
We build operating dashboards that combine CRM, ERP, QMS, service, and finance data into one view, with plain-English weekly summaries and recommended actions.
Each update can show:
- Sales pipeline by product, region, or distributor
- Open complaints, CAPAs, and service issues
- Inventory or backorder pressure
- Margin movement by product line
- Which risks need leadership attention
The goal is not prettier reporting. The goal is fewer surprises, faster action, and 4 to 6 fewer hours per week spent rebuilding the same operating report.
See the Executive Dashboard Demo →Your current tools stay in place
We build the workflow layer around your existing medical device operating environment.
Supported and common systems include:
Your QMS stays where it is. Your ERP stays where it is. Your CRM stays where it is. Your staff keeps using the systems they already know.
We add the workflow layer that reads, routes, reviews, summarizes, and writes back when appropriate.
Three focused offers
Complaint Intake and Review Acceleration System
For device teams losing too much time to manual complaint intake, triage, and escalation.
Includes
- Complaint intake mapping
- Email and form intake review
- Product, lot, site, and issue extraction
- Missing information checks
- Escalation routing
- Human review queue
- Audit log and handoff documentation
Best for
- Post-market surveillance teams
- Quality teams
- Customer support teams
- Companies with growing complaint volume
Controlled Knowledge and Regulatory Response System
For teams that need faster answers from approved documents without losing source control.
Includes
- Document source mapping
- SOP, IFU, DHF, CAPA, and risk-file ingestion
- Permission-aware retrieval
- Cited answers
- Review workflow
- Source trails
- Admin documentation
Best for
- Quality teams
- Regulatory affairs teams
- Engineering teams
- Field support and clinical specialists
Commercial Operations and Executive Dashboard System
For leaders who need one operating view across sales, quality, service, inventory, and margin.
Includes
- CRM, ERP, QMS, and service data mapping
- Leadership KPI dashboards
- Weekly narrative summaries
- Exception alerts
- Pipeline and backlog views
- Quality and service risk summaries
- Recommended action summaries
Best for
- Device manufacturers
- Distributor-led companies
- Multi-product device teams
- Operators managing growth across sales and quality constraints
Start with one workflow. Prove the ROI. Expand from there.
You do not need a full AI transformation project to get value.
The safest path is to pick one painful workflow, automate it, measure the results, and then expand once the system proves itself.
Most medical device teams start with one of these:
- Complaint intake and escalation routing
- Controlled document retrieval
- RFP and tender response drafting
- Executive operating dashboards
- Support ticket classification
- Sales and distributor follow-up workflows
This keeps the first project focused, measurable, and easier to approve.
Typical engagement range
Most medical device workflow builds start with a focused pilot.
Starter Workflow Pilot
Best for one high-value workflow
$7,500 to $15,000
Firm Automation Buildout
Best for multiple workflows or multi-department operations
$15,000 to $40,000
Ongoing Optimization and Support
Best for companies that want continuous improvement, reporting, new workflows, and support
$1,500 to $7,500 per month
Final pricing depends on workflow count, system access, data complexity, approval rules, compliance needs, validation expectations, and whether the workflow writes back into production systems.
The first step is not a giant commitment. It is a workflow fit assessment that identifies the fastest path to measurable ROI.
What waiting costs
Manual medical device workflows do not just waste time. They quietly create risk and cap growth.
Every month you delay:
- Quality teams spend time sorting complaints instead of resolving exceptions
- Regulatory and engineering leaders answer the same document questions repeatedly
- Sales opportunities slow down while RFPs and value-analysis packets wait
- Leadership decisions rely on stale exports and spreadsheet stitching
- Service and complaint patterns are noticed later than they should be
- New volume requires more coordinators instead of better workflow leverage
If your team is already stretched, better workflow design is not a side project. It is how you protect capacity, margins, and compliance discipline while the business grows.
How the engagement works
Week 1: Find the highest-value leak
We review your complaint process, document retrieval process, RFP workflow, reporting flow, support queue, or sales operations handoff.
You get:
- Workflow map
- Automation opportunity ranking
- KPI targets
- Fixed-scope recommendation
- Implementation plan
We define success before building anything.
Week 2: Build against your real workflow
We connect to the systems, documents, exports, queues, approval rules, and historical examples needed for the selected workflow.
We build around your actual process, not a generic medical device template.
Week 3: Test, tune, and review
We run real historical examples through the workflow in staging. For complaint workflows, this can include prior tickets or complaint records so routing, missing-field detection, and escalation rules can be tested against known outcomes.
You see:
- Accuracy results
- Exceptions
- Failure cases
- Confidence thresholds
- Review queue behavior
- Estimated time savings
Nothing goes live until the workflow is validated.
Week 4: Deploy, monitor, and support
We deploy the workflow, train the relevant users, monitor initial results, and support the first production cycle.
You get:
- Production workflow
- Dashboard or review queue
- Documentation
- Admin handoff
- 30 days of support
- Recommendations for the next workflow
Most builds are designed to pay back in 6 to 8 weeks of live use, depending on volume, labor cost, workflow scope, and how much quality, regulatory, support, or sales time is recovered.
Built for regulated device workflows
Medical device workflow systems have to be controlled, auditable, and reviewable.
Our systems are designed around:
- Least-privilege access
- Encrypted data in transit and at rest
- Human review thresholds
- Audit logs for AI-assisted decisions
- Source-grounded answers
- Client-owned cloud deployment when required
- Role-based access by function, product, and site
- No silent write-back below confidence threshold
- Support for 21 CFR Part 11-aligned controls where applicable
- HIPAA-aware handling when PHI may appear in complaints or support records
For teams with FDA, ISO 13485, EU MDR, HIPAA, SOC 2, or customer security requirements, we design the implementation around your compliance needs from the start.
Example outcomes
| Workflow | Before | After |
|---|---|---|
| Complaint intake | Issues sorted manually from email, forms, and support tickets | Classified intake with missing-field checks and escalation queue |
| Controlled document search | Staff hunt through SOPs, IFUs, DHF files, CAPAs, and prior submissions | Cited answers from approved sources with source trails |
| RFP and tender response | Sales rebuilds product, regulatory, and clinical language manually | Draft package generated from approved content for human review |
| Executive reporting | CRM, ERP, QMS, and service exports stitched together by hand | One operating dashboard with weekly narrative and risk flags |
| Support escalation | Field issues routed by staff judgment and inbox monitoring | Ticket classification, product context, and priority routing |
Why MVP.dev
MVP.dev builds AI business operating systems, internal tools, and automation layers for companies that need real operational outcomes, not AI experiments.
You get:
- 25 years of software architecture and delivery experience
- AI automation strategy and implementation under one roof
- Practical systems built around existing workflows
- Human-in-the-loop design where accuracy matters
- Clear KPIs before development starts
- Production-minded delivery, not prototype theater
The goal is not to impress your team with AI.
The goal is to give them time back, reduce operational drag, and help the company produce more value with the people and systems it already has.
Building the operating playbook too?
Our partners at osforyour.business/medical-devices cover the org-design, process, and people side of running a modern medical device company. We handle the execution layer that makes it run, so the system they help you design actually delivers the hours back.
Frequently Asked Questions
How much time or money can this save?
It depends on volume, but the fastest savings usually come from complaint intake, controlled document search, RFP drafting, and reporting. A small device team may recover 8 to 15 hours per week across quality, regulatory, support, and sales operations. Larger teams may save $2,500 to $10,000 per month in avoided manual work, faster response cycles, and reduced rework. During Week 1, we define the target KPIs before the build starts.
Will this replace our QMS, ERP, CRM, or PLM?
No. The goal is to improve the workflow around your current stack, not force a migration. Your QMS stays in Greenlight Guru, MasterControl, Veeva, ETQ, TrackWise, or the system you already use. Your ERP, CRM, and PLM stay in place. The workflow layer reads, routes, summarizes, and writes back only where appropriate and approved.
Can this work with controlled documents and regulated content?
Yes. We can build the system around approved document sources, role-based access, source citations, version awareness, and human review. For regulated outputs, the system should prepare, route, and summarize. Your approved reviewers still make final decisions.
Is this making regulatory or quality decisions?
No. The system can classify, recommend, summarize, flag missing information, and route items for review. It does not replace quality, regulatory, clinical, or legal judgment. Sensitive workflows are designed with review thresholds and audit trails.
Can this help with complaints and potential reportable events?
Yes. We can help structure intake, extract required details, flag potential escalation items, request missing information, and route records to the right team. Final MDR, vigilance, or reportability decisions remain with your qualified personnel.
What if our data is spread across email, QMS, CRM, ERP, and spreadsheets?
That is common. We start by mapping the workflow and identifying which systems need to be read, summarized, or updated. The first pilot usually focuses on one high-value workflow so the integration scope stays controlled.
What is the first step?
Start with a workflow fit assessment. We identify the workflow with the highest ROI potential, estimate the time or revenue impact, and recommend a focused pilot. You will know what should be built, why it matters, what it should cost, and how success will be measured before committing to a full implementation.
Get the hours and margin back
If your device company is still relying on manual complaint routing, document hunting, RFP drafting, or spreadsheet-based operating reports, there is likely a faster way to run the operation.
MVP.dev can help you identify the highest-value workflow, build the automation layer, and deploy it inside your current medical device stack.
Get a Workflow Fit Assessment See the Medical Devices Automation Demos