Avera Labs is a small team based in Bern, Switzerland. Operators who ran regulated medical device programs, decided the tools were the problem, and built the system we wished existed.
From operators, to operators.
We spent years running regulated medical device programs — writing the design inputs, surviving the audits, rebuilding the DHF three times before deciding the tools were the problem, not the team.
Regulated product development is structurally fragmented. ALM, PLM, and QMS live in separate tools with separate owners and separate data models. Traceability is reconstructed by hand before every audit. Design changes don't reach manufacturing. Post-market signals don't reach the next revision.
The fragmentation is not an organizational problem — it is architectural. Relational databases treat relationships as foreign keys; regulated development treats them as the substance of the work. The mismatch is the reason traceability is a report instead of a primitive.
Avera is the graph-native operating model that closes the loop: requirements, BOM lines, risks, test results, and supplier relationships as nodes in one graph, with an AI layer that proposes and a human gate that approves. The graph is the source of truth. The AI is an assistant with a leash. The human is the final approver of every change.
We are based in Bern, Switzerland — incorporated under Swiss law, hosting in eu-central-1, bound by GDPR, eIDAS, and ZertES by default. We chose where we are deliberately.
Founders who have 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.
Led regulated medical-device programs through FDA 510(k) and De Novo — the first-of-kind pathway used when no predicate device exists — 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. Holds the practitioner lens on the strategy engagement and on the quality-system blueprint.
Built the graph-native engine behind Avera Core after a decade of watching relational PLM and ALM tools paper over a structural mismatch between regulated development and the data model underneath it.
Believes traceability is a database primitive, or it isn't real. Leads platform engineering and the AI integration surface.
We are a small team. No listings page yet — every hire is individual, and we'd rather meet you than describe a role.
Regulatory affairs or quality leads who have shipped Class II devices through FDA or EU MDR and want to build the system they wished existed. Platform engineers who find graph databases interesting and regulatory workflows fascinating. Customer-facing operators who can lead a Roadmap engagement.
If that's you — or close enough that we should talk — write to us directly.
Everything routes to a founder. We read and respond personally.
Curiosity, partnership, or a question that doesn't fit the other boxes. One of the founders replies.
hello@avera.ioA founder call to talk through your device, your current stack, or your portfolio. No deck, no discovery form.
Request a timeProcurement questionnaires, DPAs, draft SOC 2 report under NDA. Two-business-day turnaround.
security@avera.io