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Monday, June 26, 2017
Home » FAQ » Do Medical Devices Need To Undergo Rigorous Clinical Trials?

Do Medical Devices Need To Undergo Rigorous Clinical Trials?

Medical devices are becoming more important in healthcare, and this is why many pharmaceutical firms are now focusing on developing some of them. An example of this is nanobots which are still in development, and which will be expected to work at the cellular level to treat certain conditions.

The need for clinical trials when medical devices are developed is not clear to many people. Most people assume that only drugs are subject to clinical trials since they have the potential to harm individuals if they turn out to have some unwanted effects. However, medical devices also need to go through the same process, after which they will be approved by the FDA just like normal drugs.

There isn’t much difference between medication and medical devices when it comes to clinical trials. Both usually undergo four phases of clinical trials, after which they are released for public use if approved by the FDA. In addition to that, the company responsible for them may also be required to keep monitoring the long-term use of the medical devices so as to capture any long-term side effects that may not have been apparent during the clinical trials.

Pharmaceutical firms therefore need to put in place the same mechanisms for clinical trials when they develop medical devices, and should expect to spend roughly the same amount of time in testing them as they would drugs. The importance of these clinical trials is to identify any structural or other problem that may affect the performance or safety of the medical device. Once this is fixed, the process can begin again. The end result is that the device provided to the public will be as safe as possible.

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