Improve health outcomes by developing complex, highly engineered medical equipment that meets the highest standards of performance, safety, and availability.
The first step in developing a medical device is identifying a medical need that isn’t being met. The creators begin to develop and assess the feasibility of the device, known as a “proof of concept”. Devices are designed according to their classification. There are three types of classification for medical devices that range from the least amount of risk to the most.
In the next step in development, a prototype of the device is built. This is an early version of the designed product. The prototype needs to undergo rigorous testing before it can move on to the next phase. This phase is to ensure that the device will work when tested on human subjects and reduce the risk and potential for harm.
Depending on the level of risk of the device, the pathway to approval becomes more rigorous. Class 1 devices don’t need pre-market approval, whereas Class 2 and 3 devices do. Regulatory control is the most stringent for Class 3 devices.
Once a device has passed the validation process and enough information on a device’s safety has been gathered, they can begin the application to market the device to the public.
Monitoring after the device has been introduced to the public is essential to keeping the public safe from harm. There are continuous manufacturer inspections, companies are mandated to report any problems, and the FDA will soon begin monitoring these devices in real time.
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