Implementing the MDR efficiently. 08. November 2018 The clock is ticking. The objective is to make rational use of the transitional period and develop an efficient implementation strategy. WILD Business Developer Wolfgang Stiegmaier knows a thing or two about how you can manage your MDR. The short transition period from the MDD to the new MDR is causing a headache for many medical Technology companies. What do you believe are the decisive first steps to successfully tackle this challenge? Wolfgang Stiegmaier, WILD Business Developer: „The new MDR is more extensive and considerably more precise than the MDD was. For many companies, this means they have to react quickly, as they would otherwise be forced to withdraw products currently on the market. This is, for instance, because the requirements for documentation are no longer met or the product falls into a higher class, whereby Software especially is affected. Therefore, in order to manage the transition to the MDR, it will be necessary to Analyse where the specific discrepancies are for the respective company. An essential first measure would, for example, be certification according to ISO 13485:2016. Those who meet these high requirements are mostlycapable of complying with several of the provisions of the MDR.“ How does WILD support its customers in this process? Stiegmaier: “We are currently developing a comprehensive service package designed to help our customers make their products fit for the MDR. Among others, we prepare the document requirements in accordance with Annex II of the MDR. As a contract manufacturer for medical technology, we also provide support in the risk assessment of production processes and their validation.” WILD collaborates with the consultancy firm IQC and has recently even expanded cooperation with them. Why did you take this step? Stiegmaier: “As a partner in the WILD Integrated Networks, IQC AG’s CEO Dominic Konrad has been assisting us in connection with regulatory issues for quite some time, especially with regard to our quality management system. Thanks to the cooperation with IQC, in our new Service package we can now offer our customers assistance also in the areas of product development and production.” INTERNATIONAL QUALITY CONSULTING (IQC) IQC AG is a globally operating independent consultancy firm offering advice to medical product manufacturers and pharmaceutical companies, as well as to medical technology suppliers and biotechnology companies. Its highly qualified consultants contribute their years of professional experience from working in leading positions in medical technology and pharmaceutical companies to these projects. This ensures that companies like WILD and their customers can immediately implement the imparted knowledge without discrepancies between theory and practice.