The Medical Devices Regulation requires the coordination of complex facts that have to be combined with each other. This includes, among other things, development activities, risk and usability documentation as well as pre-clinical data together with clinical data. In addition, there is data from post-market surveillance, which must be evaluated and integrated into the documentation at suitable interfaces.
How do you make sure that all requirements are taken into account? How do you maintain an overview? How do you focus on ensuring product conformity while creating the corresponding documentation with maximum efficiency at the same time?
Our experienced project managers working in certification projects have developed particular strategies to design and manage projects with focusing specifically on the critical aspects of the certification. Critical disputes with authorities and notified bodies are just as much a part of our strengths as the application of established project management standards. This ensures that with a minimum of resources your tight budget requirements are met and your product can be marketed as quickly as possible. More than ever this is necessary to be able to bring innovative and competitive products to market despite the increasing resource requirements under the new Medical Devices Regulation.
We look forward to your exciting projects. Our experts will accompany you on your challenging journey.