You have a brilliant idea for a new medical device that will improve the quality of life of many people. You think that many people are waiting for your device. Hence you want to start as quickly as possible, or maybe you are started already with a large dose of enthusiasm. And of course you are aware that the device should be safe, reliable, easy to handle, easy to maintain, etc. And most important, the main function of the device should give reliable and reproducible results. The device must deliver what the customer or user expects it is delivering. You start developing, build a prototype, test and redesign, but at some point, inevitable, you will meet the hurdle, the regulations of the FDA and CE.
This workshop illuminates the road you have to follow from customer needs to a FDA/CE certified medical device. It tells which evidence in the form of data and documents you have to produce during the development process. So, the regulations give you a lot of so called Design Control, which defines what to deliver, but they tell you not how. Design for Six Sigma is the roadmap that tells you how, and when you needs the different Six Sigma tools like QFD, System/Design-FMEA, DOE, Reliability analysis and capability.
Design for Six Sigma in Medical Device development ensures an efficient and effective development process.
University of Twente, Building Carre, Room CR 3.022