RA303 Medical Devices

Medical device regulations require manufacturers to conduct extensive testing and clinical studies to demonstrate the safety and efficacy of their products before they can be approved for sale. The regulations also require manufacturers to adhere to strict quality control standards during the manufacturing process and to track and report adverse events related to their products. The level of regulatory scrutiny for medical devices varies based on the device’s classification. In general, the higher the risk associated with a device, the more stringent the regulatory requirements. For example, Class III medical devices, such as implantable devices, require the highest level of regulatory scrutiny, while Class I devices, such as bandages or tongue depressors, have lower regulatory requirements. This course offers an understanding of topics such as; Medical Devices regulation and classification, licensing, and applicable quality standards in the US Learning Points:

• Overview of Medical Devices in the Healthcare Industry
• Medical Device & IVDD Classification
• Medical Device & IVDD Submission Types & Special Regulatory Pathways
• Post Marketing Reporting & Compliance
• Labeling. Advertising & Promotion
• Global Harmonization
• Imports & Exports