How to achieve the FDA's five-stage goals and bring medical devices to market.
While looking at examples of various medical devices, let's review the stage objectives and the statistical techniques commonly used within each stage!
From bandages to heart pacemakers, medical devices have one primary purpose: to enhance the quality of life. Medical device manufacturers must be responsible for the safety and efficacy of their products throughout the entire product development cycle. In the United States, the FDA recommends five stages for medical device development. These stages require rigorous pre-market testing and post-market surveillance to monitor the performance of medical devices, ensuring their safety and efficacy throughout the entire product development cycle. As scientists invent, improve, and test medical devices, many of these steps may overlap with one another. *For more detailed information, please refer to the PDF. Feel free to contact us for more details.*
- Company：Minitab
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