The quality management system for medical device manufacturers. Every action is an authenticated e-signature, every record lives on an append-only audit trail, and every module is connected by design — so the evidence is there before anyone asks for it.
Most eQMS platforms were assembled by acquisition — modules bolted together, signatures bolted on, evidence reconstructed after the fact. The week before an audit tells you everything about a quality system.
A document releases — and someone has to remember to update training. The gaps between modules are where audit findings live.
With MedDev: modules hand off to each other automatically, in one transaction. Nothing falls between.
Screenshots, exports, and binder-building — reconstructing proof of work the system should have kept all along.
With MedDev: the audit trail writes itself as work happens. Show it on demand, any day of the year.
Implementation projects measured in quarters and invoices measured in commas — while small device teams run quality from spreadsheets.
With MedDev: start with the modules you need, when you need them — built for teams that actually build devices.
Three decisions sit underneath every module — made once, inherited everywhere.
Approvals, dispositions, training completions, verifications — each one re-authenticates the signer and records who, when, and what it means. Signatures are bound to the record, not pasted near it.
§ Authenticated e-signatures · manifested meaning · 21 CFR Part 11The audit trail is append-only — enforced in the database itself, not promised in a policy. History can be read, exported, and inspected. It cannot be edited.
§ Append-only audit · enforced at the data layerThe system does the busywork — routing, handoffs, drafts, reminders — and a human verifies and signs before anything that matters proceeds. Fast where it accelerates, accountable where it counts.
§ Human-verified before progression · every action attributableSome things in a quality system are genuinely hard to keep clean. We took the ones teams struggle with most and built the answer into the foundation — so the right thing happens by default, and the record protects itself.
A controlled document gets revised. The standard doesn't just ask that affected people be retrained — it asks that the effectiveness of that training be evaluated, with a method proportionate to the risk of the work. That's where systems fall short: a minor editorial fix triggers the same heavyweight sign-off as a critical process change, so teams either over-burden everyone or quietly skip the effectiveness step.
A change request is waiting on an approver who's suddenly on leave. Most systems force you to recall the request, swap the person, and restart every approval — or it stalls. We built delegation in, with guardrails that protect the integrity of the record.
CAPA is one of the most-cited problem areas in the industry, and the failure is consistent: systems let a CAPA close on implementation — the action was taken, the box was checked. But the standard expects evidence that the action actually worked and the problem didn't come back. That verification step is where teams fall short.
Built in as core, not bolted on. The connection between modules isn't a reminder someone has to honor — it's the architecture.
Most teams build their own metrics in spreadsheets and quietly wonder whether the numbers are right. MedDev Automation computes them from the same record that captures the work — set up correctly from day one, updating in real time, and designed to actually move the process forward.
This is Gap 01, measured. When a document changes, did training actually complete on time? Here's that exact question — answered live, from the record itself.
Quality is the core, not the boundary. Adopt the full platform or start with the modules your team needs — each one ships when it meets the bar, all on the same signature and audit backbone.
“I've sat on both sides of the audit table. This is the system I always wished existed — built the way an auditor reads, not the way a vendor sells.”
Before the doors open to everyone, a small group of medical device manufacturers will shape what ships — and lock in founding terms that never come back. This isn't early access to unfinished software. It's a seat at the table while the table is still being set.
Seats open alongside the first working demo, late 2026. Join the waitlist now to be first in line when applications open — waitlist members are invited before anyone else.
Field-tested quality resources written by a Certified Lead Auditor — the same thinking going into the platform, available to your team now. More arriving as we go.
A practical, section-by-section self-assessment for the move from the QSR to FDA's Quality Management System Regulation — the gaps ISO-certified teams miss, the evidence to pull, and a remediation plan that doubles as your transition record.
We're not raising right now — but if you want to follow the build, a short monthly note from the founder covers what shipped, what we learned, and where it's going. No pitch, no spam.
We're building this right — validated, documented, and audit-ready before it ever reaches a customer, targeting launch in 2027. Waitlist members hear from the founder first, get first access, and shape what ships as design-partner spots open up.