Strategy · Capability · Platform
Strategy, team, and platform — built on one graph that connects every requirement, BOM line, risk, and test result from concept through post-market.
Built by operators who have taken Class II medical devices through FDA clearance — including De Novo, the first-of-kind pathway — and EU MDR. From operators, to operators.
Three structural defects in how regulated devices get built today — and three reasons every program runs late.
Walled off.
ALM, PLM, and QMS sit in separate tools with separate owners. Changes don't cross the wall; they get re-typed.
Sequential.
Requirements → design → V&V → manufacturing → post-market runs as hand-offs, not concurrency. Every stage waits.
Stale.
Trace matrices are reconstructed weeks before audits. The DHF is always a retroactive artifact, never a live view.
The fragmentation is not just organizational. It is architectural.
Ventures, corporates, engineering firms, and investors buy different outcomes — on the same underlying operating model.
Strategy, capability, and the platform that delivers your first submission — without rebuilding the DHF twice.
For founders & CTOsConsolidate ALM, PLM, and QMS without ripping and replacing in a quarter. Migration at release boundaries, never mid-cycle.
For SME & corporate R&DThe platform your teams use to deliver more value per engineer — co-branded, with shared roadmap input.
For regulated-services partnersHelp your medical-device companies clear faster, with less burn — and cleaner technical diligence at exit.
For VCs & family officesNot a software vendor that bolted on services. A coordinated delivery model with three equal offerings — strategy, enablement, and the platform.
A practitioner-led engagement that produces a defensible pathway to clearance, a quality-system blueprint, and a development plan calibrated to your runway.
Structured upskilling of your core team on the meta-model, traceability, and review workflows — hands-on with your own program data.
Graph-native workspace with LiveDocs, Explorer mount, and Claude-via-MCP proposals. Billing starts only once the team is certified.
Billing on the platform starts only after the team is certified. You don't pay for unreadiness.
Deterministic core beneath a probabilistic intelligence layer, separated by an explicit human approval gate. Not a feature — a structural choice.
Proposes, challenges, improves.
Drafts risk analyses, V&V protocols, submission sections. Claude via MCP. Context-scoped to the nodes it touches.
↓ Human approval gate ↓
System of record.
Immutable audit trail. Electronic signatures (eIDAS, ZertES). Graph-native traceability. 21 CFR Part 11 compliant.
No training on customer data. Every API call audited. Per-item opt-in. The graph is the source of truth; the AI is an assistant with a leash.
Avera was built by people who have run regulated medical-device programs end-to-end — from first design input through FDA clearance (510(k) and De Novo), EU MDR, and post-market surveillance.
We've sat in the regulatory chair, the design chair, the manufacturing chair, and the audit chair. We know what every existing tool gets wrong because we used them all.
Not consultants who studied this market. Operators who lived in it, and built the system we wished existed.
Led regulated medical-device programs through FDA De Novo and EU MDR clearance. Hired the RA/QA teams, survived the audits, and rebuilt the DHF three times before deciding the tools were the problem.
Built the graph-native engine behind Avera Core after a decade of watching relational PLM and ALM tools paper over a structural mismatch. Believes traceability is a database primitive or it isn't real.
A 30-minute call with the founders. Tell us about your device. We'll tell you the path.
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