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Radiometer, a global market leader in blood gas and immunoassay analyzers, has selected Technia, a subsidiary of Addnode Group, as a global implementation partner for RoHS2, REACH analysis and documentation based on ENOVIA Materials Compliance™ Central from Dassault Systèmes.
In the first implementation phase, the solution enables Radiometer Medical in Copenhagen to meet the RoHS2 directive, effective July 22nd, 2014 for medical devices. The directive states that an analysis and documentation has to be completed in line with RoHS (Restrictions of Hazardous Substances) as a prerequisite for the CE Mark (which in turn is the prerequisite for placing the medical device product on the European market). In the following phases the solution will be rolled out at additional sites worldwide, cover additional regulatory areas i.e., REACH and Conflict Minerals, and drive material compliance and sustainability decisions from initial design and sourcing to product obsolescence.
Verner Karlsen, RoHS/REACH Program Manager at Radiometer Medical, states, “The key to success in our RoHS and REACH initiative is efficiency in retrieving up-to-date product and material information from across the complete supply chain. Therefore the Microsoft Dynamics AX (ERP) and BOMCheck integrations are essential parts of the solution”. Verner continues, “we value Technia’s strong track record in medical device and diagnostics industries as well as their strong partner network in the material compliance domain”.
Jonas Gejer, CEO at Technia comments “The tight timeline imposed by the RoHS recast requires a mature and rich solution combined with a fast and light PLM implementation. Hosted ENOVIA MCC, as a turnkey solution for material compliance, reduces implementation time down to two to four months even with full ERP and BOMCheck integrations active (for ERP systems such as SAP, Lawson, Movex, Oracle, etc). For the medical device industry the implementation time has to be reduced to a minimum, freeing up time to cope with regulatory and design challenges rather than implementing and validating IT solutions."