Regulatory Compliance
DOCUMENTATION
& CERTIFICATION
Full CE compliance support for 3D printed products. From risk assessment to technical file preparation, we manage the entire regulatory process.
Analysis
Product risk assessment
We identify potential hazards associated with the product, assessing mechanical, electrical, thermal, and chemical risks.
Material documentation acquisition
We collect technical data sheets, certifications, and declarations of conformity for all materials used.
REACH compliance verification
We verify that all materials comply with REACH chemical substances regulation.
Production
Production parameters documentation
We document all printing parameters: temperatures, speeds, infill, orientation, and post-print treatments.
Testing and reporting
We perform mechanical, thermal, and functional tests with detailed reporting of results.
Documentation
Technical File preparation
We compile the complete Technical File with all documentation required by applicable directives.
Instructions and warnings drafting
We draft user instructions, safety warnings, and manuals in the language of the destination country.
Certification
EU Declaration of Conformity
We prepare the EU Declaration of Conformity attesting compliance with all applicable directives.
CE marking application
We apply the CE mark on the product or its packaging according to regulatory specifications.
Ten-year archival
We retain all technical documentation for at least 10 years as required by regulation.