The objective of the EU Medical Device Regulation (MDR) is to protect patients against defective medical products or those that carry risks. Unifying the European legislation on medical products will protect patients against medical products that are associated with risks. Previous abnormality surrounding faulty breast implants and artificial hips had destroyed patients' confidence in the safety of medical products.
The implementation of the Medical Device Regulation requires a significant investment of time and money for manufacturers of medical products.
This is exactly where rantronik has stepped in to support its customers in the field of medical engineering with its many years of experience and expertise. From advice and planning for a master validation plan, to the creation of risk analyses and the necessary qualification and validation documents, all the way through to the performance of tests on a diverse range of systems, rantronik takes responsibility for the entire range of tasks in close collaboration with its customers. This has involved the qualification and validation of systems and processes in accordance with the MDR, for example injection-molding and extrusion machines, partial and complete assembly systems as well as packaging systems. The service package from rantronik includes drawing up the final reports as well as providing support for the submission of the necessary documents to the appropriate authorities.
Are you about to make the changeover to the MDR in your company or have you already started the process and need additional support?
Then please do not hesitate to get in touch – we would be happy to answer all your questions regarding qualification and validation in line with the MDR.