PRODUCT LEVEL
Whether you develop the product yourself or bring it to the EU market from a third country: the product must meet the relevant requirements.
At product level, we determine which properties your product must have.
This also includes product markings and further technical documentation. We identify the relevant requirements and support you in considering them already during product development and product selection.
Research into Guidelines & Standards
Function, design and intended use determine which EU requirements apply to a product.
During classification, we identify the applicable directives, regulations and product standards—for example in the areas of machinery, EMC, low voltage, RoHS, REACH, PPWR or WEEE.
Risk Assessment & -analysis
Hazards are systematically identified and the associated risks assessed. We expand upon the ISO 12100 framework to ensure the risk analysis is comprehensive. Wherever possible, the necessary protective measures are incorporated directly into the design in collaboration with your development team.
Our risk analyses are tailored to each specific case, without relying on fixed templates or off-the-shelf software. This is the only way to achieve the goal of creating unique products.
Technical Documentation
Preparing and compiling legally compliant technical files:
What is not documented has not happened.
User Information & Instructions
Operating instructions, warnings, and markings are integral parts of a safe product. Intended use, limitations, and necessary safety measures are clearly communicated.
EU Declaration of Conformity & CE
The EU Declaration of Conformity summarizes the legal acts applicable to the product and confirms compliance with them.
The CE marking is affixed to the product in accordance with the applicable requirements.
Result
Early identification and consideration of requirements enable streamlined processes for development, procurement, and market launch. Safety, functionality, and product compliance cannot simply be verified at a later stage.
The product level lays the foundation for robust market access.