The connected platform for medical device innovation
From first ideas to mature products: designs, risks, tests, processes, files, submissions, complaints, every improvement, and every unit in the field, in one system of record. Operational in days.
The path to a proven product is years of versions, variants, approvals, and feedback loops. Every change fans out across risk, V&V, submissions, manufacturing, and the fielded fleet, each in a different system, each a human handoff. That's where speed dies and runway burns.
Years
of versions, approvals, and feedback loops before a device earns its place.
Every change
fans out across risk, tests, submissions, and the fleet, and someone chases it by hand.
Avera replaces the stitch-together stack with a single connected system, and it keeps every artifact current, automatically.
One platform, not four
The four systems you'd otherwise license, integrate, and validate separately, unified and ready in days.
Everything connected
Every requirement, part, risk, test, document, and fielded unit lives once, linked to everything it affects. Your trace matrix, DHF, DMR, and technical file are never rebuilt; they're always current.
The whole chain lives in one system of record: nothing rebuilt, re-keyed, or reconciled. We walk it live, end to end, in a 30-minute demo on a complete demo device.
A complaint on a fielded unit, or a market need worth a next version. Trace it to the exact lot, BOM revision, and design version.
Requirements, hardware design, BOM, risk file, documents, not just software. Next-generation work continues untouched.
Across risk, V&V, manufacturing, regulatory, and the field, all visible before you commit.
No to-do list for four other tools: the updated BOM revision, the line-revalidation protocol, the work-instruction update, and the submission section are the same items the impact pointed at, with AI drafting the volume work as proposals a named human approves. The impact list is the work list.
Rev D releases with its updated BOM and revalidated line. Each market's authorization record carries the decision: letter-to-file here, a new filing there. Release is gated where approval must come first.
The trace enumerates the affected units; the retrofit is recorded against each unit's device history; the complaint closes against the fix, or the market need ships.
That loop is where device companies slow down and burn out. In one system of record, it's days.
D0 · Start in days
Item types, workflows, forms: proposed by AI, reviewed and approved by you. Proven foundations included free: a complete QMS, device template, and validation kit.
D1 · Lose the busywork
No more collecting, comparing, and re-keying records across systems. Change once; it's reflected everywhere. Files included: Avera Drive puts them in macOS Finder and Windows Explorer, controlled.
D2 · Your AI drafts the work
Risk analyses, protocols, submission sections: AI proposes, you approve. Your model, your keys; no training on your data; every change attributable.
Continuous improvement, required by ISO 13485, stops being a burden: change is cheap and safe, so your quality system stays living and your product keeps getting better.
Clear the bar with less burn: runway goes to the device, not the tooling.
Founders viewA program of record that accelerates R&D: design ↔ risk ↔ V&V on one connected system.
Engineering viewAudit-ready by construction; never rebuild the trace matrix.
Quality viewA living technical file: see the impact of any change across every market.
Regulatory viewA clinical evaluation wired into your design, risk, and claims.
Clinical Affairs viewAn always-current DMR; see how a design change hits parts and suppliers before you commit.
Manufacturing viewRegulatory, design, manufacturing, audit chairs: we've sat in all of them, end to end, through design control, clearance, audits, and post-market.
Not consultants who studied the market. Senior operators who built the system they wished existed.
Our operators get you live fast, then step back. Bootstrapping, enablement, and data migration from legacy systems over Avera's open interfaces. If you want it, never a dependency.