Preserving Your Swing

Two Important Medical Device Testing Questions You May Be Asking

Technological advances have allowed for miraculous medical devices to be created, and these devices have the power to save an almost countless number of lives. Yet, the human body is highly complex, and this means that these devices must be thoroughly tested before they are approved for distribution. However, the process of testing these devices is rather complex, and if you have been tasked with overseeing this process for your business, you may have a couple of questions that you are needing addressed. 

Why Does It Take So Long To Test Medical Devices?

Many people are shocked to learn that it can take several weeks or months for testing of these devices to be complete. Interestingly, the actual testing of the device will not take that long in most cases. Rather, the majority of the time needed to do this work is for configuring the testing fixture. 

The testing fixture is designed to subject the device to any stresses that it may encounter when it is on the market. Due to this, it is critical for a proper testing fixture to be designed and built, and this can take several weeks if your device is particularly complex or needs highly specialized components. 

What Type Of Report Will You Receive After The Testing Is Complete?

At the end of the testing process, a highly detailed report will be prepared for you or your engineer to review. These reports will detail how the device performed under each test and at each point in the test. In instances where the device fails a particular test, the cause of the failure and conditions at the time of failure will also be included. 

There may be instances where there is specific information that your company's engineers will need to review or improve the medical device. In order to ensure your enterprise gets the most from these tests, you should have your engineers prepare a list of the information they will need and provide this information to the testing company. This will ensure that they capture the information that you need from this testing process. 

Developing a new medical device is one of the most complex feats of engineering that your company can do. However, these devices must undergo rigorous testing before they can be approved for distribution. By knowing the answers to these routine questions about medical device testing, you will be in a far better position to ensure this process goes smoothly for your company.


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