Cloud MES for medical device manufacturing
Replace paper with digital your team will actually use.
Built specifically for growing medical device manufacturers, WorkStepper™ digitizes work instructions, production records, and traceability—without the cost, complexity, or lengthy implementation of traditional enterprise MES.
Built for FDA Part 820 & Part 11 · No on-prem servers · First work instructions 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.
Built for FDA Part 11 and Part 820
Part 11 e-signatures, a locked audit trail and controlled revisions are part of how it runs, and we support your validation so you're not starting from scratch.
Live up and running fast
Upload your existing Word or PDF 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. Every work order runs a released revision — no drafts, no pencil edits.
Paperless DHR & eDHR
Every step, reading, check and signature is captured as the work happens, so the completed work order is the device history record.
Lot & traceability
Capture lot and serial numbers on the work order and component lots at the step. Look up the work orders that used a lot in seconds, not days.
Real-time floor visibility
Your floor plan, live: who is working on what, what's waiting in each Work Cell's queue, and where an Andon just went up.
Scheduling & capacity
Plan each technician's week against real capacity. Overloads, blocked work and missing estimates show up before they cost you a ship date.
NCRs that close the loop
Open an NCR from the out-of-spec reading, record the disposition, and require the rework to be done before it closes.
Compliance & validation
Part 11 controls built in, not bolted on.
E-signatures, an audit trail that can't be edited or deleted, and controlled revisions are part of how WorkStepper runs. We support your validation with IQ and OQ protocols for the platform and a PQ template for your process, so you don't build it from scratch.
- 21 CFR Part 11 electronic records & signatures
- 21 CFR Part 820 (QMSR) quality system support
- IQ / OQ / PQ validation support
- Audit trail that can't be edited or deleted
Questions
Frequently asked questions
The things small device manufacturers ask us most.
- Is WorkStepper built for FDA 21 CFR Part 820 and Part 11?
- Yes. WorkStepper is built for FDA-regulated medical device manufacturing: Part 11 electronic signatures that record identity, meaning and reason, an audit trail that can't be edited or deleted, and controlled template revisions. Validating it for your intended use stays your responsibility — we support it with IQ and OQ protocols for the platform and a PQ template for your process, and work through them with you.
- How long does implementation take?
- Your first work instructions can be running within days, and a first product line live in weeks — no consultants, no months-long rollout. Upload your existing work instructions as Word files or text-based PDFs, our AI converts them into template steps, and you start from your real process instead of a blank page.
- Can WorkStepper schedule our floor?
- Yes. The Schedule plans each technician's days against a daily capacity, shows the week's load for the whole shop and for each Work Cell you set capacity for, and flags overloads, blocked work and missing estimates. Scheduled work orders show a planned finish, and routed jobs that aren't planned yet show a projected finish from capacity.
- Does it work on a tablet at the bench?
- Yes. Operators run steps on a tablet or a bench PC. Tap a picture to open it full screen with pinch and double-tap zoom, or enlarge an instruction's text up to 48 px. The full-screen viewer's controls are sized for gloved hands.
- How does WorkStepper handle nonconformances?
- An out-of-spec reading can open an NCR with the observed values already on it. Closure is always e-signed, and dispositions and approvals take an e-signature or a written reason, as you configure. Use as is needs a written justification, and you can require the rework steps to be complete before a rework NCR closes — controls that map to ISO 13485 §8.3, which the QMSR (21 CFR Part 820) incorporates.
- 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 work instructions?
- Yes. Upload your current work instructions as Word files or text-based PDFs, and WorkStepper's AI parses them into structured template steps that you review, edit, and release — far less effort than retyping every traveler.
- 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. Importing one takes minutes.