MDR Ready

Product Certification- MDR

Since May 26th, 2017 when the new European Medical Device Regulation (MDR – directive EU 2017/745
& IVDR – directive EU 2017/746) has been established all medical device suppliers are working under high pressure to implement these standards to assess the conformity of their products. Hence, all processes related to design, industrialization, manufacturing, marketing and market surveillance have to be aligned with the quality management system which must be compatible with ISO 13485:2016 and/or USA QSR. Due to our top-level expertise and a wealth of experience we advise and support our global customers in updating and correcting their documentation. We offer this service to successfully accelerate
procedures along the entire life cycle of medical devices to keep the products safe. Our clients know that we fully adhere to their industrial standards and that we stand for personal assistance, fast response times, on time delivery and the highest level of flexibility!