Regulatory Affairs for Medical Devices

BGI - Sustainable Ventures

Learn all about the rules and regulations governing medical devices in this online course!

Welcome to our online course focusing on Regulatory Affairs for Medical Devices*! Whether you're a Health Startup or a Research Group, this course will provide valuable insights into navigating the complex world of regulations governing medical devices, especifically through FDA in the US.Join us for expert-led sessions, interactive discussions, 1:1 mentoring sessions and practical tips to help you ensure compliance and bring your products to market successfully.Don't miss this opportunity to expand your knowledge and network with a expert in the field.Register now!-----Topics to be discussed:<a href="https://tinyurl.com/4hkz3deu" title="https://tinyurl.com/4hkz3deu" target="_blank" data-msys-clicktrack="0" rel="nofollow noopener noreferrer">For more information click here</a>US Regulatory: Pre-Market ( 1:30 hour /per session) | 🗓️ April 28th <ol><li>US Regulatory Plan</li><li>US Medical Device Classification</li><li>US FDA Regulatory Pathway</li></ol> US Regulatory: Post-Market ( 1:30 hour /per session) | 🗓️ April 29th <ol><li>Quality Management System</li><li>US Registration and Listing</li><li>Import Requirements</li><li>Change Assessment</li><li>US Post-Market Safety Monitoring</li></ol> Specific Session: IVD Medical Devices ( 1:30 hour /per session) | 🗓️ April 30th <ol><li>IVD Definitions</li><li>IVD classifications</li><li>IVD labeling requirements</li><li>Premarket notification requirements</li><li>FDA guidance on IVDS</li></ol> <ul><li>1:1 Mentoring Session (30 minutes) | 🗓️ To be scheduled</li></ul>Personalised session with the expert where your startup can: <ol><li>Clarify specific doubts regarding their medical devices</li><li>Receive tips and mentoring regarding regulatory strategy</li></ol> ---BGI is offering a discount of 10% over the base value to <a href="https://eithealth.eu/our-network/our-supported-start-ups/?country=&amp;launch_year=&amp;min_funding=0&amp;max_funding=100&amp;industry=health" title="https://eithealth.eu/our-network/our-supported-start-ups/?country=&amp;launch_year=&amp;min_funding=0&amp;max_funding=100&amp;industry=health" target="_blank" data-msys-clicktrack="0" rel="nofollow noopener noreferrer">EIT Health portfolio companies</a>, and to BGI alumni.---About the Expert:<a href="https://www.linkedin.com/in/eric-bannon-8790767/" title="https://www.linkedin.com/in/eric-bannon-8790767/" target="_blank" data-msys-clicktrack="0" rel="nofollow noopener noreferrer">Eric Bannon</a> is Senior Vice President of Regulatory and Clinical Affairs at AlvaMed - has 40 years of experience providing regulatory and clinical support for medical device companies. His expertise focuses on implementing creative regulatory and clinical strategies from development through commercialization with experience in multiple therapeutic areas both in the US and abroad. ---Should you have any questions, do not hesitate to ask: ricardo.ribeiro@bgi.pt or marta.grencho@bgi.pt

*A minimum of participants is required for the implementation of the course. If that is not accomplished the registration fee wil be returned or a new date scheduled for the implementation of the course.

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Regulatory Affairs for Medical Devices

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