Verio — design controls as a document

Verio turns the YAML behind a medical-device software release into something you read and write like a document: requirements with full traceability, the IEC 62304 documents, the software architecture, a SOUP list, and an ISO 14971 risk analysis — one file, one editor.

Its defining constraint: every edit is a minimal diff. Edits are spliced into the YAML text using the parser's byte ranges, so untouched lines stay byte-identical, comments and block-scalar styles survive, and a one-line edit produces a one-line diff. Design control lives in change control; the file diff is the review.

How it works

• Verio sits in the activity bar. Its view holds the navigation tree — Project, Documents, Design (risk management, requirements, architecture, SOUP), Verification, Validation, and Changes — and the editor shows the document alone.
• It finds the workspace's design.yaml by itself, and follows whichever design editor is active. Any *.design.yaml opens the same way.
• Everything is edited in place. Titles and identifiers are edited where they are read; descriptions rest as rendered markdown and become a live editor when clicked, with the caret where you clicked.
• Documents, not forms. The requirements and the architecture read as one scrolling document, numbered by position (1, 1.1, 1.1.1 — computed, never stored), foldable down to an overview.
• Creation happens at the seams. Hover between two items for the line with a +; where levels meet, the pointer's distance picks the level. Nothing opens a dialog.
• Drag and drop to reorder or reparent — in the requirements and in the architecture. A move re-indents the block without rewriting it; a move and a move back restore the file byte-for-byte.
• Risk management the ISO 14971 way: hazards and harms defined once, referenced by risks; severity × probability estimates with a 5×5 matrix; control measures that cite the requirements verifying them, with renames rewriting references.
• SOUP fills itself from the project's own dependencies and refreshes versions on demand.
• Changes compares the working design against a git tag or commit — design-level, not textual: which items were added, removed, changed or moved, with word-level highlighting and a one-click revert per change. The compared revision is stored in the file, so the whole team measures against the same baseline.
• Native document lifecycle: edits go through VS Code's text document — Cmd+Z, dirty state, Cmd+S — and you can keep the YAML open in a split text editor; both stay in sync.

The file

design:
  risk_management:   # hazards, harms, risks
  requirements:      # user need → requirement → specification → test
  architecture:
  soup:

The format is described by JSON schemas shipped in the repository (root.schema.json, architecture.schema.json, risk.schema.json). Files written with the sections at the top level still open; verio design restructure moves them into the groups without touching a line of content.

A companion CLI (verio design export) renders the same file to a numbered PDF review document, and verio design check verifies every cross-reference holds.

Getting started

1. Install Verio and click its icon in the activity bar.
2. If the workspace has a design.yaml (or any *.design.yaml), the tree is already there. If not, create an empty design.yaml — an empty file is a valid starting point; the first item you write creates its section.