CE, certifications, and a technical file without the panic phase
Regulatory
Expert-level knowledge of CE, RED and the CRA, with a lawyer's eye
Like the best regulatory specialist you have worked with: knows which requirements apply to your product and has the material ready before anyone asks.
Which directives apply to the product on the new market? Where is the latest version of the declaration? The technical file is complete, you believe, but nobody dares swear to it. And the regulations change faster than anyone has time to track.
What I take off your desk
Concrete work, not promises. Everything is a proposal; you approve.
The requirement picture per product and market
I maintain the list of directives, standards, and requirements that apply to your products, updated when the rules change.
A technical file in order
I watch that the file's parts exist, are current, and fit together, and flag the gaps before the notified body does.
Draft declarations
Declarations of conformity and similar documents drafted from your own product data, ready for review.
Test material for the lab
Compiled material ahead of certification testing, so lab time goes to testing and not to follow-up questions.
What it looks like
Labelling and radio requirements from the regulatory documentation, with the standards they reference.
Driven by
- Market access without delays
- A technical file that is always complete
- No surprises from new regulations
Measured on
How your digital colleagues work
The same rules for every colleague, built in from the start.
They know your business
The colleagues read your own documents and your own business data. No generic answers; your part numbers, your customers, your processes.
They propose, you decide
Every draft and every change goes through you or a flesh-and-blood colleague. Nothing is published without human approval.
Everything is traceable
Every document is a plain file in a version-controlled repository you own. You always see who changed what and why.
You are never locked in
All your knowledge can be exported at any time, in open formats. It is your data, not ours.
More colleagues in Product Development
Curious what it feels like?
We run pilot programs with a few manufacturing companies at a time. Tell us about your business and we will show what the colleagues can do with your documents and your data.