Cloud MES for medical device manufacturing
From paper to production-ready.
WorkStepper is cloud-based MES software built for small medical device manufacturers. No IT team, no consultants, no months-long implementation — just your process, digitized and FDA-ready from day one.
Built for FDA Part 820 & Part 11 · No on-prem servers · Live in days
The cost of paper travelers
Binders don't scale. Neither do the risks they carry.
If you're still running work orders on paper, you already know the failure modes. Each one is a missed shipment, a finding, or a late night waiting to happen.
Records you can't find in an audit
A reviewer asks for a specific lot's history and the team starts pulling binders. Paper travelers go missing, get coffee-stained, or sit in someone's drawer.
Transcription errors and missed steps
Handwriting gets misread. A step gets skipped and nobody notices until final inspection — or worse, after the device ships.
Hours lost to manual review
Every DHR is reviewed line by line by hand. Your quality team spends more time chasing signatures than improving the process.
No real-time view of the floor
Where is each work order right now? With paper, the only honest answer is a walk to the floor and a stack of questions.
Why WorkStepper
The digital infrastructure of a large company — without the overhead.
WorkStepper gives small manufacturers enterprise-grade discipline, sized and priced for a team without a 50-person IT department.
Built for your floor, not a 500-person factory
Most MES platforms assume an enterprise IT team. WorkStepper assumes you don't have one. Configure your process and start running.
FDA-ready from day one
Validation documentation for Part 820 and Part 11 comes built in, so you're not starting from scratch.
Live up and running fast
Upload your existing work instructions and our AI converts them into template steps — so you start from your real process, not a blank page. No consultants, no months-long implementation.
Product capabilities
Everything a device manufacturer needs to run paperless.
Each capability replaces a stack of paper with an enforced, traceable digital step.
Digital work instructions
Turn paper travelers into guided, enforced work steps. Operators follow the right revision every time.
Paperless DHR & eDHR
Every action, signature, and check is captured automatically into a complete, review-ready device history record.
Lot & traceability
Track components, lots, and serials end to end. Pull a full genealogy in seconds, not days.
Real-time floor visibility
See where every work order stands, what's blocked, and what's ready — without leaving your desk.
Compliance & validation
Validation built in, not bolted on.
Validation packages for FDA Part 820 and Part 11 are built in, not bolted on. You get the documentation you need without building it from scratch — and an audit trail that holds up to a reviewer's questions.
- 21 CFR Part 11 electronic records & signatures
- 21 CFR Part 820 Quality System support
- IQ / OQ / PQ documentation included
- Complete, tamper-evident audit trail
2-minute compliance overview
Demo video placeholderFrom the floor
Trusted by small device makers going digital.
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Questions
Frequently asked questions
The things small device manufacturers ask us most.
- Is WorkStepper FDA 21 CFR Part 820 and Part 11 ready?
- Yes. WorkStepper is built for FDA-regulated medical device manufacturing. It provides Part 11 electronic records and signatures with a complete, tamper-evident audit trail, and ships with validation documentation for Part 820 — so you are audit-ready from day one.
- How long does implementation take?
- Most teams are up and running fast. There are no consultants or months-long rollouts — you upload your existing work instructions, our AI converts them into template steps, and you start from your real process instead of a blank page.
- Do I need an IT team to run WorkStepper?
- No. WorkStepper is cloud-based with hosting, automatic updates, and onboarding included. It is designed for small device manufacturers that do not have a dedicated IT department.
- Can WorkStepper import our existing paper work instructions?
- Yes. You can upload your current work instructions and WorkStepper's AI parses them into structured template steps that you review, edit, and release — dramatically reducing the effort to move off paper.
- How is WorkStepper priced?
- Pricing is straightforward and scales as you grow — no enterprise contracts or surprise implementation fees. You start with the essentials and add capacity as your floor expands. Request a quote tailored to your team.
Move your floor off paper.
See WorkStepper running on your own work instructions. Setup takes minutes, not months.