MDR Readiness: We help you to get there!
Since May 26th 2021, the Medical Device Regulation is fully applicable. 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.
We help you to get there - Due to our top-level expertise and a wealth of experience we advise and support our global customers in updating and correcting their technical documentation. With this service, we ensure to successfully accelerate procedures along the entire life cycle of medical devices to keep the products safe. We stand for personal assistance, fast response times, on-time delivery and the highest level of flexibility.
Contact us to learn more about using our 7 steps strategy for full compliance of your tech files.