From bandages to pacemakers, medical devices have a single, primary purpose: to improve the quality of life. Medical devices companies must be responsible for the safety and effectiveness of their products throughout the entire product development cycle. In the U.S., the FDA recommends five stages for the device development process. These stages ensure the safety and efficacy of medical devices in the whole product development cycle, creating a need for rigorous pre-market trials and post-market surveillance activities to monitor the performance of medical devices.
In this webinar, we will explore the stage goals and the statistical techniques typically conducted within each stage through examples of different medical devices.
