AI-Native Design Control Platform

Risk management built into
the design, not bolted on
after the fact.

Schevra is the intelligent workspace where medical device engineers do the real work of design control — generating, refining, and linking risk analyses, design inputs, and traceability — before exporting polished, audit-ready outputs into your QMS.

Request Early Access See the Platform →
ISO 14971 FDA 21 CFR Part 820 EU MDR 2017/745 510(k) · De Novo DHF

The Problem

Design control is a
disconnected afterthought.

Engineering teams are focused on prototyping and iteration. Regulatory requirements demand that risk management, design inputs, and traceability develop in parallel. In practice, they never do.

  • ✕
    No single tool connects user needs, risk analysis, design inputs, and verification — teams maintain 4–6 disconnected documents that fall out of sync immediately.
  • ✕
    AI is completely absent from design control — engineers write every requirement, risk statement, and control from scratch.
  • ✕
    Junior engineers lack embedded regulatory guidance — costly mistakes are caught late in development or at submission.
  • ✕
    Traceability matrices are built manually at the end of the program, taking weeks and creating significant audit risk.
  • ✕
    Component-level risk analysis is rarely linked to system-level risk — exactly the gaps regulators flag on inspection.

The Platform

An integrated workflow
from device concept to
submission-ready DHF.

Engineers describe their device. Schevra generates a contextually accurate starting point — user needs, hazard profiles, design inputs, and traceability links — which the team refines and owns. Risk management and design control treated as one integrated system, not parallel documents.

  • ✓
    Design inputs generated directly from risk analysis — the critical connection most tools miss entirely.
  • ✓
    ISO 14971 compliance engine flags gaps and cites specific clauses inline — non-blocking, advisory.
  • ✓
    Traceability matrix auto-populated from upstream work — not assembled manually at submission time.
  • ✓
    Dual FDA and EU MDR framework coverage in a single intelligent workspace.

Why Schevra

Built by engineers who
have lived this problem.

⚡

AI-native from the ground up

Not a document editor with AI bolted on. The entire workflow is designed around intelligent generation and engineer refinement — from the first intake question to the final traceability export.

🔗

One integrated workflow

Risk management and design control treated as a single connected system — the missing link between how engineers actually develop devices and what regulators require them to document.

✦

Design inputs from risk analysis

The critical connection every other tool misses. Schevra generates specific, standards-referenced requirements directly from the risk analysis — not independently, not manually.

📋

Dual regulatory framework coverage

FDA 21 CFR Part 820, 510(k), De Novo, and EU MDR 2017/745 — all in one workspace. Engineers don't manage parallel documentation for parallel submissions.

🏗

QMS-agnostic by design

Schevra is where engineers do the thinking work of design control. Polished, traceable outputs flow into whichever QMS the company uses. We don't replace your QMS — we make the inputs to it extraordinary.

🎓

Embedded regulatory guidance

Junior engineers get ISO 14971 expertise at their fingertips. Standards knowledge embedded in every prompt, every suggestion, every flagged gap — not surfaced only when something goes wrong at submission.

Early Access

Be among the first
to build with Schevra.

We're working with a select group of medical device teams before our general release. If your team is building a Class I, II, or III device and is tired of risk management as a last-minute scramble — let's talk.