Greenlight Guru Webinar: Clinical Considerations for Software and Artificial Intelligence (AI) / Machine Learning (ML)

Isabella Schmitt, Director of Regulatory Affairs at Proxima, is here to help webinar participants learn how to formulate the right questions for regulatory & clinical considerations for medical device software and artificial intelligence and machine learning practices.

Innovate smarter and not harder by taking key considerations including when an AI solution may be needed and identifying appropriate research questions and best practices for engineering and deploying the model effectively based on industry and the FDA’s SaMD (Software as a Medical Device) regulation guidance.

For all of those interested in learning about this timely topic, register for this free, in-depth webinar now!

Specifically, this webinar will cover:

• Valid clinical association, analytical validation, clinical validation, and good machine learning practices
• Practical implications software developers should be aware of that range from ethical concerns about algorithmic bias to legislative concerns
• Circumstances when an AI solution may be needed and identifying appropriate research questions
• Best practices for medical device engineering and deploying the model successfully based on the MedTech industry and the FDA’s SaMD regulation guidance