Device manufacturers that incorporate particulate testing into their product-development plans early are better equipped to navigate the regulatory clearance process and potentially reduce time to market.

Particulate testing of cardiovascular medical devices is an important and valuable step on the road to regulatory clearance, market success, and patient safety. Device manufacturers that incorporate particulate testing into their product-development plans early are better equipped to navigate the regulatory clearance process and potentially reduce time to market. After premarket regulatory clearance is achieved, and the cardiovascular device is on the market in clinical use, postmarket lot release particulate testing and monitoring can help ensure product quality and safety going forward.