What occurs during preclinical testing in the medical device life cycle?

During preclinical testing in the medical device life cycle, testing is conducted in laboratory settings before the product is used in humans. This stage primarily focuses on evaluating the safety, efficacy, and performance of the device through various methods, such as bench testing, animal studies, and other forms of analysis that simulate the intended use of the device. The aim is to gather sufficient data on the potential risks and benefits of the device prior to proceeding to clinical trials.

This phase is crucial as it ensures that the device is safe for initial human trials and helps inform the design of those subsequent studies. Data collected during preclinical testing is essential for regulatory submissions and for obtaining approvals to move forward with clinical testing.

In contrast, market launch refers to the actual release of the medical device into the marketplace, which occurs after all testing and regulatory processes are complete. Clinical trials with human subjects take place after preclinical testing, assessing the device’s effects on actual patients. Final regulatory submission involves compiling data, including that generated during preclinical testing and clinical trials, to submit to regulatory authorities for approval, rather than being a stage of preclinical testing itself. Thus, option C accurately reflects the activities associated with preclinical testing.