Navigating the AI Regulatory Landscape
with TÜV SÜD AI Expert Kenneth Fuh PhD.
Navigating the AI Regulatory Landscape featuring TÜV SÜD AI Expert Kenneth Fuh PhD.
From executive orders to new global regulation, Join Thomas Regulatory Compliance Group and TÜV SÜD AI Expert Kenneth Fuh PhD to discover key insights into proactive strategies, addressing bias, and the ever-evolving regulatory guidance landscape. Get practical tips for operationalizing AI activities and insights on how use cases impact risk.
Chapter List
Click below to see a description of each topic and the timestamp for where that discussion begins.
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Dr. Fuh walks us through how he became a TUV AI Subject Matter Expert, and gives us a pulse-check on the overall AI/ML regulatory landscape.
Related Services: AI Overview Training
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Dr. Fuh discusses the impact of President Biden's executive order directing the development of a safety program for AI and machine learning in healthcare; and puts it in context with other global regulation activities.
Related Services: AI Overview Training
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A discussion on the state of global AI MedTech enforcement.
Related Services: Quality System Optimization, Software Design Process Assessment
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Dr. Fuh explains the EU AI Act’s classification, and its impact beyond Medical Devices.
Related Services: Quality System Optimization
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Dr. Fuh discussing some of the key considerations when Notified Body Product Assessor’s review AI/ML enabled devices.
Related Services: Quality System Optimization, Software Design Process Assessment
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Dr. Fuh outlines how to interpret “state-of-the-art” with these broader suite of regulations.
Related Services: Quality System Optimization, Software Design Process Assessment
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The dangers of Data & Algorithm bias are discussed, along with how developers can minimize this risk.
Related Services: Data & Algorithm Bias Assessment, Software Design Process Assessment
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Dr. Fuh explains “EU Values”
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Dr. Fuh describes what’s in the EU AI Act and how it works with existing Device regulation.
Related Services: Quality System Optimization
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We speculate on the impact of President Biden’s AI Executive Order including what we can expect in future guidance.
Related Services: Data & Algorithm Bias Assessment, Software Design Process Assessment, Quality System Optimization
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Dr. Fuh gives his advice for manufacturers and developers, including things they should start doing now, and what they should begin doing differently.
Related Services: Quality System Optimization, Software Design Process Assessment
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Dr. Fuh offers his thoughts on how having a human in the intended use process impacts risk classification.
Related Services: Quality System Optimization, Software Design Process Assessment
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Changes coming from China and how they relate to the overall changes we see globally.
Related Services: AI Overview Training
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Tips on keeping up with regulatory changes.
Related Services: AI Overview Training
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How pediatric use cases will impact risk, and considerations for manufacturers/developers.
Related Services: Data & Algorithm Bias Assessment, Software Design Process Assessment, Quality System Optimization
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Tips for operationalizing and governing AI development, ethics, bias, and general technology regulation for MedTech firms.
Related Services: AI Overview Training, Software Design Process Assessment, Quality System Optimization, Data & Algorithm Bias Assessment
Associated Services
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Quality System Optimization
Our Quality System Optimization service is tailored to preemptively align your quality system with upcoming AI regulatory changes, safeguarding against unexpected issues during inspections or product submissions. By proactively adjusting and fortifying your quality processes, we ensure that your organization remains ahead of the regulatory curve, promoting compliance and minimizing the risk of disruptions in the approval process.
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Data & Algorithm Bias Assessment
Systematically evaluate and rectify potential biases within your datasets and algorithmic processes — aligning with regulatory requirements. This meticulous assessment not only ensures a more equitable and ethically sound system, but supports the regulatory approval process by proactively addressing bias concerns, paving the way for a better performing, and more effective product for your customers.
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Software Design Process Assessment
Assessing your Design Controls process’ ability to systematically generate objective evidence may not only ensure compliance, but also improve time-to-market. Make your next submission offer a streamlined path that accelerates approval timelines and bolsters confidence in your product’s reliability, safety, and adherence to Good Machine Learning Practices.
Let’s Work Together
Interested in learning more about how TRCG can assist with your Digital Health and MedTech needs? Our team is happy to meet with you to craft tailored solutions to your Quality and Regulatory Compliance concerns.
Future Webinars
Visit our webinar page to find our calendar of upcoming webinars, let us know topics you’re interested in seeing, and be kept in the loop for all future webinars.
Quick Takes
Dr. Fuh’s AI Regulation “Temperature Check”
From the AI Executive Order to guidance from China and the pending EU AI Act, Dr. Fuh shares a quick overview of the AI regulation space.
Advice for Manufacturers
With all of the changes going on, Dr. Fuh gives his top tips for Manufacturers to stay ahead of the curve.
AI Governance
As with any new topic, the best way to systemically manage it can be a challenge for your organization. Dr. Fuh and Khalil share their thoughts on how AI can best be governed in your organization
Bias
With no shortage of headlines highlighting instances of Algorithm bias, Dr. Fuh gives his thoughts on mitigating these issues.