Our customers benefit from our experience in the implementation of the MDR and IVDR guidelines. We support them along the whole process of the market entry and offer all services related to regulatory demands. We organize clinical studies and performance evaluations in European labs for our customer's products, help in creating the whole technical documentation, offer advice in how to fulfil labelling compliance, register their products with the different health authorities in all European countries, help them in obtaining the CE certificate and offer implementation of seven different ISO standards in their company.
Diagnostics | Electromedical Equipment / Medical Technology | Medical Furniture and Equipment | Laboratory Equipment | Services and Publications