Total Product Life Cycle (TPLC)

Before a new medical device can receive marketing authorization, regulators evaluate its safety and effectiveness. One of the most important questions asked is whether the clinical benefit of a medical device outweighs its risk. Patients can provide valuable input about how they evaluate potential risks and benefits of a medical device and provide insight into the design and development of new technology. Patients, caregivers, and patient advocates have a deep and personal understanding of what it is like to live with a disease, and they often have valuable insights on how a device could affect their quality of life.

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