Life Expectancy Of Cardiovascular Devices: The Fda Conisderations& Requirements
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Abstract
Cardiac implantable electronic devices are designed to help control or monitor irregular heartbeats in people with certain heart rhythm disorders and heart failure. Medical devices must meet strict regulations for both efficiency as well as security. The FDA checks for developing safety concerns once a medical device is on the market as part of our ongoing commitment to promote patient safety, and will take appropriate action when we become aware of problems that could threaten patients. In order to optimize the expected lifespan of medical devices and to ensure that it is accessible and in great condition when patient care is provided, lifecycle management is crucial. Presently, a number of obstacles prevent wearable technologies from being widely used in healthcare settings. Devices will become increasingly capable and an essential tool in our tools for cardiovascular practise as sensor and computing technology advance. For the purpose of ensuring their efficacy and safety, these devices must be regulated through evaluation frameworks and sufficient regulatory oversight procedures.
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