The REACH and RoHS regulations and the revised Medical Devices Act (MPG) present new challenges to the medical devices industry – one of the most highly regulated industries. Implementing the regulations requires both changes in processes and extensive communication costs. tec4U will support you all the way.
tec4U is a medical device industry service provider covering all product design requirement compliance issues. Whether processing material data with tec4U’s own MDS.web software or in third-party systems, tec4U ensures data transparency and data security. This applies for example to the requirements imposed by REACH, RoHS and the Medical Devices Act (MPG), which may result in a high level of product risk.
Beginning as early as the design phase, tec4U will provide you with material compliance support in the form of risk assessments concerning the materials used. Subsequently, tec4U will assist you in supplier communications and the evaluation of supplier material data. The services provided by tec4U include merging the data on the overall product and communicating the data to the customer. In addition to monitoring the material data, tec4U will also provide you with guidance on material substitution issues. In implementing all of these tasks, tec4U builds on the “5-Step Plan”, in combination with MDS.web, its own communication software.