What is the goal of preclinical testing for medical devices?

The primary goal of preclinical testing for medical devices is to evaluate safety and performance prior to human clinical trials. This stage of development is critical, as it involves extensive laboratory and animal studies designed to identify any potential risks, side effects, or efficacy issues associated with the device. By rigorously assessing how the device functions and how it interacts with biological systems, developers can make necessary adjustments to enhance safety and effectiveness before proceeding to clinical trials involving human subjects.

Conducting thorough preclinical testing helps to minimize risks during later phases of development and also supports the regulatory approval process, as agencies like the FDA require robust evidence of safety and efficacy before allowing human testing to commence. This proactive approach not only protects potential patients but also enhances the overall credibility of the device within the medical community.