Who it's for

One positioning. Four entry points.

Ventures, corporates, engineering firms, and investors buy different outcomes. They share the same underlying truth: regulated product development is structurally fragmented, and Avera is the unified graph that fixes it.

The homepage commits to the truth. This page translates it for who you are.

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Ventures Companies Engineering firms Investors
01 · Medical Device Ventures

From concept to cleared device — without rebuilding twice.

Who this is for Founder-CEO, CTO, or VP R&D at a pre-clearance medical device company. Seed to Series B. Often building Class II. Hiring the first RA/QA lead. Burning capital to milestones.

Most ventures discover the regulatory and quality problem too late. The first product gets built in spreadsheets, Word documents, and Jira. By the time a serious RA/QA hire arrives, the DHF has to be reconstructed from scratch — costing three months and a milestone.

The alternative — buying Jama, a separate PLM tool, and a QMS at seed stage — burns capital on tools the team can't operate yet.

Avera's model is different.

  • The RoadmapA 4–8 week, fixed-fee engagement that produces a defensible regulatory pathway, a quality-system blueprint, and a development plan calibrated to runway.
  • The CapabilityStructured enablement of the core team — typically 2–4 people — on the meta-model, traceability, and review workflows. Hands-on with the venture's own data.
  • The EnginePlatform activation once the team is certified. Per-seat pricing aligned with team growth. You don't pay for unreadiness.
  • No tool sprawlOne platform replaces ALM, PLM, and QMS — and grows with you.
  • AI does volumeDrafts risk analyses, V&V protocols, and submission sections. Your team reviews and approves.
  • Audit-readyBuilt for the audit you'll have in 18 months, not just the standup today.
Tell us about your device. We'll tell you the path.
Book a strategy call
02 · Medical Device Companies

One graph. Three disciplines. No more rebuilding traceability before every audit.

Who this is for Head of R&D, VP Engineering, Head of Quality, CIO at an established medical device company (50–5,000 employees). Runs Jama or Polarion, Windchill or Arena, plus a separate QMS.

If you run Jama, Windchill, and a separate QMS, you already know the cost: weeks of trace-matrix reconstruction before every audit, design changes that don't propagate to manufacturing, post-market signals that never reach the next revision.

The cost isn't the license fees. It's the engineering time spent stitching tools together, and the regulatory risk of working from stale views.

  • Impact analysisChange a design input, see every affected output, V&V protocol, and risk control in seconds. No JOIN queries, no exports.
  • AI as QA layerContinuously scans for orphaned items, missing traces, contradictions across DHF / DMR / technical files. Not just generation — review.
  • Live submissions510(k), eSTAR, MDR technical files generated from live graph data. When the design changes, the submission knows.
  • Closed-loop PMSA field complaint connects to the affected BOM line, risk control, and regulatory filing in one query.
  • Migration pathAssess → Pilot → Migrate at release boundaries → Consolidate. Never mid-cycle. Legacy tools retire on your schedule.
  • Validation packageIQ/OQ/PQ documentation provided. 21 CFR Part 11 eIDAS/ZertES electronic signatures. Per-tenant isolation you choose.
Walk us through your current stack. We'll show you the path off it.
Book a platform conversation
03 · Engineering Firms

Deliver more value per engineer in regulated programs.

Who this is for Partner, Practice Lead, or Head of Medtech at a regulated-engineering services firm. Billable models under pressure as AI improves engineer productivity. Need to deliver more outcome per engagement.

AI is changing what engineering services looks like. Hourly billing meets a team that produces twice as much per hour. Clients ask whether they need the firm at all.

The answer is yes — but only if the firm delivers what the client cannot replicate alone: regulatory-grade outputs, on a platform built for the work, with practitioner expertise wrapped around the AI.

Avera is the platform that makes that possible.

  • Your team, our engineYour engineers deliver client engagements on Avera. The platform handles traceability, AI generation, and audit. You bring judgment, domain depth, and the client relationship.
  • Co-brandedJoint go-to-market with named medical device clients. Case studies that strengthen both brands.
  • Shared roadmapYour client needs feed Avera's roadmap. You shape the platform that powers your delivery.
  • Why nowThe market is consolidating around a small number of platforms. Firms that pick a platform partner now will be the firms whose delivery looks differentiated in three years.
Let's design a pilot engagement together.
Talk to us about partnership
04 · Investors

Help your medical device portfolio clear faster, with less burn.

Who this is for Partner or Principal at a venture fund or growth-equity fund with medical device exposure. Corporate venture arms. Family offices with medtech holdings.

Funds use Avera to derisk submissions, accelerate timelines, and tighten operations across their medical device holdings. Three ways to engage — one underlying truth about time to clearance.

  • Faster clearanceA unified platform plus AI removes the bottleneck that delays submissions: rebuilding traceability, drafting technical files, coordinating across disciplines.
  • Lower DD riskWhen a portfolio company runs on Avera, technical files are current, traceability is provable, and the audit story is one query away.
  • Lean opsTwo practitioners with Avera replace the four-person regulatory team a portfolio company would otherwise hire at Series B.
  • Cleaner exitsAcquirers do their own technical diligence. A graph-native, audit-current DHF makes diligence smooth and the price defensible.
  • Portfolio introWe work with your portfolio companies on a fund-rate engagement — strategy first, then platform if it fits.
  • Diligence supportWe audit a target's regulatory and quality state pre-investment, and identify the path to clearance with a defensible cost.

We don't replace your investment judgment or your operating partners. Our model is to build the capability inside the portfolio company, then step back. We don't share data between portfolio companies.

Let's talk about your medtech holdings.
Book a portfolio conversation
From operators, to operators

Every conversation starts operator to operator.

A 30-minute call with the founders. No deck. Tell us what you're building, or what you're buying into.

Book a conversation