Regulatory
Requirements from the directives
CE, RED and the standards you follow, connected to your products and documents instead of to a binder.
How you work it in Colleag
- 1
Ask the colleague to connect the directives' requirements to the product.
- 2
The colleague reads the directives and standards you have uploaded against your documentation.
- 3
Review the mapping: requirement, covering document, gaps.
- 4
Approve the requirement register; it is then watched continuously.
A worked example
“What does RED require of the X200 and where do we show compliance?”
The requirements from the directive with the document covering each: test report, declaration or risk assessment, and the gaps listed. Everything points at your own documents so an audit can follow the chain.
Screenshot from Colleag. The example uses invented figures.
The material
- Directives and standards you have uploaded
- The technical file
- Test and risk documents
You approve
Everything the colleague produces is a proposal with sources. Nothing is published, sent or saved to the archive without a human approving it, and every figure traces to its material.
More from Regulatory
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.