US FDA 510(k) Pre-Market Notification (PMN) Submission requirements for Sterile Medical Devices
Sterilization technologies have undergone a remarkable evolution over the years, driven by advancements in science, technology, and healthcare practices. From traditional methods like heat and radiation to more sophisticated techniques such as ethylene oxide (EO) and vaporized hydrogen peroxide (H2O2), the landscape of sterilization has continually expanded to meet the increasingly stringent demands of modern […]
