Complete file for an active product line

The website featured a specification sheet, and that was it. The documents required to build a technical file were non-existent: no user manual, no drawings, no electrical diagrams, and no bill of materials. For a regulator, a specification sheet does not constitute a file.

We determined which legislation was applicable and had the devices tested. The measurements passed immediately, so no changes were needed for the product. Subsequently, the missing documentation was requested, and the reports underwent a second review before the file was compiled.

Six weeks after the kick-off, the technical file was complete, with the declarations of conformity ready for signature. Since then, every device is accompanied by a declaration and the user manual.