What is the medical device development process?

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What is the medical device development process?

2020-08-06T17:41:30+00:00December 27th, 2018|

The development of medical equipment can be done in two ways: The first is the fast track route, which refers to the process of developing medical equipment that is already on the market, i.e., upgrading existing medical equipment. The second way is to develop new medical equipment from beginning to end. As with the development of any new product, even within the framework of medical device development, the process begins with the development of a prototype. Subsequently, various experiments and tests are performed to check the safety of the various devices and to obtain preliminary approval from the Ministry of Health to proceed. After this step, clinical research should be performed to evaluate the safety and efficacy of the medical devices in a representative group of patients. Upon completion of the clinical study and analysis of its results, applications may be made to obtain required regulatory approvals and, upon approval, the device marketing process may begin.

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