Product safety
We support the product towards compliance: from legislative and regulatory compliance and CE-marking support to risk assessment and the drafting of the technical file.
From design to market
Product compliance and safety
An integrated path that delivers a safe, compliant product.
Regulatory scouting and CE marking
We identify the directives and regulations applicable to the product according to its target markets — CE marking for Europe, FDA or UL requirements for the United States — defining the project's legal compass before investing in production.
Chemical and environmental compliance
We verify compliance with directives on hazardous substances and environmental impact — RoHS, REACH, SCIP and the packaging regulation — for products that remain compliant across the whole supply chain.
Risk assessment
We apply standard methodologies — FMEA (Failure Mode and Effects Analysis) and ISO 12100 for machinery — to identify mechanical, electrical, thermal and chemical hazards and correct them in advance.
Technical file and documentation
We draft the Technical File (drawings, calculations, test reports), user manuals, warnings and hazard labels, and support the preparation of the Declaration of Conformity through which the manufacturer assumes legal responsibility for the product.
Products for potentially explosive atmospheres — ATEX
Support in assessing the risks and ignition sources of products intended for use in potentially explosive atmospheres — flammable gases, vapours, mists and combustible dusts. We assist before notified bodies in developing and filing the technical file and in issuing the ATEX EU Declaration of Conformity.
ICIM Group partnership: SCIP and packaging
Since 2020 we have partnered with ICIM Group on extended producer responsibility and material compliance, supporting the development of a UCIMU Guideline for SCIP Notification aimed at member companies. Again with ICIM Group, we developed a vademecum on EU and non-EU packaging regulations — a practical guide to applying the labelling obligations in force, which differ from country to country.
Areas of expertise