Avera unifies design control, product lifecycle management and quality management in a single graph-native system — so you build traceability as you go, not reconstruct it before submission.

The integrated AI works in two modes: it generates content — drafting regulatory submissions, test protocols, and manufacturing documentation from live product data — and it reviews content, challenging traceability for consistency, flagging gaps in coverage, and detecting contradictions across design, manufacturing, and regulatory domains. Everything the AI proposes requires human approval before entering the validated system.

Enterprise-grade validation, electronic signatures, and audit trails are built in from day one.

Start fast with validated templates and pre-configured workflows for design controls, risk management, and quality procedures. As your product matures, Avera grows with you — from first prototype through regulatory submission, design transfer, and commercial manufacturing. Submissions become predictable because the data is already structured, traced, and complete. Production transfers are streamlined because BOMs, work instructions, and DHR records live in the same system as your design history.

After launch, Avera closes the loop. Field complaints, CAPA, and post-market surveillance feed directly back into the design and manufacturing graph — so a trend in the field drives a change that flows through to affected BOMs, risk controls, V&V protocols, and regulatory filings automatically. For complex installed bases with multiple device variants, configurations, and revision levels, Avera's branching architecture keeps every version managed and every change traceable across the full fleet.

Built in Switzerland by a team that has taken complex devices through FDA De Novo & 510(k) and EU MDR pathways into clinical adoption.

Avera Labs

Org chart

Teams

Offices