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CE-compliant system development
Goal: ensuring the CE conformity of your machine
Wir entwicklen Ihre Maschine gemäß der Vorgaben, Normen und Richtlinien, die im Land herrschen, in dem die Maschine betrieben werden soll. CE conformity in plays a particularly important role here. By affixing the CE marking, you as the manufacturer or distributor confirm that the machine complies with the product-specific applicable European directives (e.g. Machinery Directive). For this, we take several steps in the course of product development:
- Intended use: together with you, we determine the intended use of your product and the groups of people who will later handle it.
- Identifying CE directives: we identify the relevant CE directives for your machine and the consequences resulting from them. Furthermore, we identify additional requirements or concrete options in the country of operation (so-called “transposition into national law”).
- Researching harmonised standards: we determine whether so-called harmonised standards exist that are applicable to your product.
- Requirements and conditions: we clarify which specific requirements and conditions are derived from the standards for your product.
- Notified body: in this step we clarify, whether or not a “notified body” such as e.g. a testing laboratory or another authorised third party needs to be involved in the conformity assessment procedure.
- Conformity assessment procedure: during a hazard analysis or risk assessment, we gain knowledge of the hazard groups relevant to your machine, the consequences thereof, the origins of the hazards and the hazard locations. We determine necessary protective measures and assess whether the risk is eliminated or minimised to a sufficient degree.
- Technical documentation: we prepare the technical documentation for your machine in accordance with EU specifications, including operating instructions, instructions for use, assembly instructions if applicable, EC type certificate, circuit diagram, etc.. We also supply the necessary translations for the countries in which the product is used.
- EU Declaration of Conformity: we draw up the Declaration of Conformity, which you as the manufacturer or distributor only have to sign.
- CE marking: You may now affix the CE marking to your product including the identification number of the Notified Body (if this was required), e.g. as an imprint on the type plate.
- Observation of legal regulations and the current state of the art: as a result of previously unknown or recognised risks, re-testing, rework and new certifications may become necessary for your product. On request, we regularly check whether there are any changes to the standards and directives relevant to you and how the technology is currently developing.
Goal: CE-compliant machine documentation
Correct technical documentation is a component of the specifications for CE conformity. This makes it a natural part of machine development projects for us. Sometimes it happens that a company has carried out a machine development independently and only needs support in the preparation of the technical documentation. Here, too, we can help. We prepare the technical documentation for your machine in accordance with EU requirements, including operating instructions, instructions for use, assembly instructions (if applicable), EC type certificate, circuit diagram, etc.. Here we have the advantage that our “editors” are machine developers themselves and therefore look in the right places and ask the right questions. We also supply the necessary translations for the countries in which the product is used.
Contact your expert
Head of Overall Development
+49 (0) 7251 firstname.lastname@example.org