Navigating AI Risks for Regulatory Approval in Medical Devices

Navigating AI Risks for Regulatory Approval in Medical Devices

Speaker: Isabella Schmitt | Proxima CRO

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About this course

Are you prepared to effectively mitigate AI risks and secure regulatory approval for your innovative medical device? Join us for an enlightening webinar led by Isabella Schmitt, MBA, RAC, VP of  Life Science Solutions, as she unveils the transformative power of Artificial Intelligence (AI) in the MedTech landscape. Gain invaluable insights on approaching AI implementation in medical devices from an FDA regulatory perspective.


As you consider incorporating AI into your medical device, it is imperative to be fully aware of the potential risks associated with this groundbreaking technology. Our webinar will delve into the impact of AI on medical device development, explore the potential risks associated with integrating AI, and provide guidance on designing algorithms with a clear vision of the end-user in mind.Building a medical device that incorporates AI necessitates a comprehensive understanding of the potential risks associated with this cutting-edge  technology. In this webinar, we will focus on the following key benefits:
- Ensuring algorithm generalizability to your patient population
- Mitigating the introduction of biases during AI integration
- Designing transparent algorithms for end-users and FDA evaluation

 

By participating in this webinar, you will gain the knowledge and insights necessary to navigate the complex landscape of AI regulation effectively. This will empower you to mitigate risks and accelerate your path to regulatory approval.

Curriculum0 hr 50 min

  • Welcome!
  • Session Recording 0 hr 50 min

About this course

Are you prepared to effectively mitigate AI risks and secure regulatory approval for your innovative medical device? Join us for an enlightening webinar led by Isabella Schmitt, MBA, RAC, VP of  Life Science Solutions, as she unveils the transformative power of Artificial Intelligence (AI) in the MedTech landscape. Gain invaluable insights on approaching AI implementation in medical devices from an FDA regulatory perspective.


As you consider incorporating AI into your medical device, it is imperative to be fully aware of the potential risks associated with this groundbreaking technology. Our webinar will delve into the impact of AI on medical device development, explore the potential risks associated with integrating AI, and provide guidance on designing algorithms with a clear vision of the end-user in mind.Building a medical device that incorporates AI necessitates a comprehensive understanding of the potential risks associated with this cutting-edge  technology. In this webinar, we will focus on the following key benefits:
- Ensuring algorithm generalizability to your patient population
- Mitigating the introduction of biases during AI integration
- Designing transparent algorithms for end-users and FDA evaluation

 

By participating in this webinar, you will gain the knowledge and insights necessary to navigate the complex landscape of AI regulation effectively. This will empower you to mitigate risks and accelerate your path to regulatory approval.

Curriculum0 hr 50 min

  • Welcome!
  • Session Recording 0 hr 50 min

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