Plain language, your facts
One question at a time, in your words. Every explanation carries what it means for you, what happens if it is ignored, and where the law says so. No jargon on the main path — ever.
EU MDR · CLASS I · SPECTACLE FRAMES, LENSES, READERS
Your name is on the frame. In EU law, that makes you the manufacturer.
Specta takes eyewear brands from “we sell frames made in China” to a defensible technical file and a completed EUDAMED registration — asking you plain questions, asking your factory in Chinese, and explaining every step before you approve it.
122 requirements · 116 verified against primary sources · every one carries its legal citation — the full registry is available to signed-in clients, reviewers and advisors.
Nothing is invented
Every sentence in your file binds to a document you uploaded or a legal clause we cite. A validator rejects anything unbound — there is no override switch.
Your factory is asked precisely
Missing evidence becomes a one-page request in Simplified Chinese naming the document, the clause and the exact standard edition. Wrong editions bounce automatically, with the reason.
You sign informed, or not at all
Each step teaches before it asks for your approval. Before the final declaration you pass a short comprehension check — because a signature you can’t explain won’t protect you.
Eight steps, one dossier
From “what even is this product, legally?” to a registered device with ongoing surveillance.
- M1 Scope, role and classification
- M2 Foundation
- M3 Evidence
- M4 Clinical evaluation
- M5 Product information
- M6 Declare
- M7 Register
- M8 Keep
You answer the business facts once. Specta determines — with citations — what your product is, which law applies and who the legal manufacturer is; collects and checks the evidence from your factory; writes the technical file under a citation validator; and prepares your EUDAMED registration package, validated against the official schemas before anything is submitted.
Three faces, one engine
一页一个请求 — one request per page
No accounts, no English, no guessing. A link opens exactly what is needed and why; uploads are checked on arrival, and anything wrong comes back immediately with the reason, in Chinese.
Built to be audited
An append-only, hash-chained log of every approval, every rejection and every generated sentence — exportable and verifiable by a third party without trusting us.