This 4-day course will navigate the 510(K) clearance process and De Novo classifications requests for United States (U.S.) and global Medical Device Manufacturers and regulatory affairs leaders to improve the ability to bring new and improved devices to the U.S. marketplace.
Course Audience
• U.S. and global (e.g., European Union, Association of Southeast Asian Nations) quality and regulatory affairs leaders for Medical Device Manufacturers (MDM).
• MDMs of new device technologies, such as those developing mobile applications.
Key Benefits
• Learn about all the elements and documentation required in a 510(k) submission.
• Plan your design project for 510(k) clearance.
• Reduce time to market through full regulatory comprehension and strategic planning
• Lower your company’s dependence on consultants by bringing the regulatory expertise in-house
For more information: https://us-tdm-tso-15eb63ff4c6-1626e-169df4b0a12.force.com/s/lt-event?id=a1Y2E000007VJUP