A quality system that lets a small workshop make a regulated device
editorialManufacturing & Supply · nothing open · hardest part: regulatory, manufacturing, capital
Open designs exist in quantity. Almost none can be legally manufactured and sold, because the barrier is a documented quality system, not a CAD file.
This is editorial, not a record. Registry entries are cited facts about things that exist; an opportunity is our argument about something that does not. The links to existing work are checked against the catalog — the judgment around them is ours, and you should disagree with it where you know better.
Regulated manufacture requires a quality management system, design history files, traceability, complaint handling, and audits. That machinery is affordable to a company amortising it over volume and prohibitive for a workshop making hundreds of units. The consequence is a large body of open medical hardware that never legally reaches a patient — the designs are free and the compliance is not.
An open, reusable QMS template targeted at small-scale regulated manufacture, plus worked examples: one device carried end to end through design controls, verification, and a submission, with the paperwork published as a pattern. Also open tooling for traceability and BOM management that produces audit-ready records rather than spreadsheets.
Every open hardware project currently stuck at prototype, and any region that would rather manufacture locally than import. This is the highest-leverage gap in the catalog: it unblocks a whole class of projects rather than one device.
Nothing in the registry addresses this. That may mean the gap is real, or that our catalog has a hole — tell us if it is the second.
None cited. Everything above is either reasoning about market structure or a claim you should check yourself. Where we could not source a number, we left it out rather than estimating one.
Last revised 2026-08-05.