What Medical Devices Aren’t Regulated By The FDA?
Learn what medical devices are and aren’t regulated by the United States Food and Drug Administration (FDA) and how the FDA classifies medical devices.
Learn what medical devices are and aren’t regulated by the United States Food and Drug Administration (FDA) and how the FDA classifies medical devices.
Learn about the importance of medical devices in healthcare, and their current benefits as well as facility and patient-related risks regarding its usage.
Learn how the FDA classifies medical devices, what means each classification, and how to determine the classification of your medical device or product.
Learn about sterilization and the top seven sources for microbial contamination of medical devices and products.
Learn about the differences between cytotoxicity and microbiology testing, and when your medical device needs cytotoxicity and microbiology testing.
Learn how EO residual testing compares to environmental monitoring and how these tests relate to regulatory testing for medical devices or products.
Learn about the differences between bacterial endotoxin testing and environmental monitoring for your medical device or medical product.
Learn about steam sterilization, dry heat sterilization, and which method to use to sterilize various medical devices and products.
Learn about sterilizing bacterial spores, why they are hard to kill, and how to create sterilization processes to fully sterilize your medical devices.
Learn how to control equipment and protocols that laboratory technicians use for microbial testing of medical devices and aseptic processing environments.