FDA Compliance in the Age of AI: Navigating the New Frontier of Machine Learning in Healthcare
Ensure Your AI/ML Innovations Align With Evolving FDA Regulations for Safer Healthcare!
Instructor :
Jose Mora
Webinar ID:
12429
Date: NOV 26, 2025 (TUE)
Start Time: 10 AM PT - 11 AM PT
Duration: 1 Hr.
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“Cut Through the Complexity of AI Regulations and Modern 510(k) Pathways!”
2 Courses Included:
Why Pack Them Together? As technology evolves, so do the regulatory landscapes. This pack offers essential insights into two critical areas of innovation: AI in healthcare and modernized device approvals. Professionals can stay informed on cutting-edge topics and prepare to navigate new regulatory challenges.
Why Buy the Pack?
-
- Stay Ahead in Innovation: Perfect for companies adopting AI technology or developing new devices that need to meet modern regulatory standards.
Buy This Course in a Pack of 2 courses at 25% Discount HERE:
🚀 The Future-Ready Innovation Pack: Navigating AI and Modern Regulatory Pathways
“Cut Through the Complexity of AI Regulations and Modern 510(k) Pathways!”
2 Courses Included:
Why Pack Them Together? As technology evolves, so do the regulatory landscapes. This pack offers essential insights into two critical areas of innovation: AI in healthcare and modernized device approvals. Professionals can stay informed on cutting-edge topics and prepare to navigate new regulatory challenges.
Why Buy the Pack?
-
- Stay Ahead in Innovation: Perfect for companies adopting AI technology or developing new devices that need to meet modern regulatory standards.
- One-Step Solution for Emerging Trends: Combines two hot topics to provide a comprehensive view on where regulations are headed, making it ideal for forward-thinking professionals.
- Special Bundle Pricing: Get both courses at a reduced rate, saving you money while offering critical insights.
Note: Do you want to custom design your pack and choose courses of your choice? Just drop us an email at support@compliancemeet.com or call at Toll Free: +1 (888) 959-4972. We’ll be happy to help you!
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What will you learn
-
- Understand Total Product Life Cycle For AI/ML Design
- Apply FDA Pre-Cert Program To Streamline AI/ML Approvals
- Master Algorithm Updating And Dataset Quality Control Requirements
- Conduct Standalone And Clinical Performance Testing For AI/ML Systems
- Learn FDA’s Labeling And Explainability Requirements For AI/ML Software
- Ensure Data Enrichment And Effective Database Management Compliance
- Address Cybersecurity Considerations For ….
-
- Understand Total Product Life Cycle For AI/ML Design
- Apply FDA Pre-Cert Program To Streamline AI/ML Approvals
- Master Algorithm Updating And Dataset Quality Control Requirements
- Conduct Standalone And Clinical Performance Testing For AI/ML Systems
- Learn FDA’s Labeling And Explainability Requirements For AI/ML Software
- Ensure Data Enrichment And Effective Database Management Compliance
- Address Cybersecurity Considerations For Safe AI/ML Healthcare Applications
Course Description
Artificial Intelligence (AI) and Machine Learning (ML) are transforming the future of medicine by making diagnosis and treatment more efficient and accessible. However, when it comes to regulatory oversight, traditional FDA guidelines for medical software don’t fully cover the unique, evolving nature of AI/ML programs.
Unlike conventional software, AI/ML continuously learns and adapts after deployment, meaning the field version of the software often differs from the validated version initially approved by the FDA.
This creates a significant compliance challenge for organizations looking to integrate these cutting-edge technologies while adhering to FDA regulations.
In this 60-minute training, you will learn:
-
- How the FDA traditionally regulates medical software and where AI/ML fits in.
- Why current regulations fall short for continuously learning AI/ML programs.
- Key strategies to ensure FDA compliance even as your AI/ML systems evolve in real-time.
Key Takeaways:
-
- Navigate the regulatory landscape for AI/ML in healthcare.
- Understand the gap between FDA-approved versions and post-deployment software updates.
- Learn actionable steps to align your AI/ML innovations with evolving FDA requirements.
Stay ahead of the curve in the rapidly changing world of AI/ML and FDA compliance. Ensure your technology not only pushes boundaries but also meets regulatory standards, so you can safely and effectively bring innovative healthcare solutions to market.
Enroll Now!
Artificial Intelligence (AI) and Machine Learning (ML) are transforming the future of medicine by making diagnosis and treatment more efficient and accessible. However, when it comes to regulatory oversight, traditional FDA guidelines for medical software don’t fully cover the unique, evolving nature of AI/ML programs.
Unlike conventional software, AI/ML continuously learns and adapts after deployment, meaning the field version of the software often differs from the validated version initially approved by the FDA.
This creates a significant compliance challenge for organizations looking to integrate these cutting-edge technologies while adhering to FDA regulations.
In this 60-minute training, you will learn:
-
- How the FDA traditionally regulates medical software and where AI/ML fits in.
- Why current regulations fall short for continuously learning AI/ML programs.
- Key strategies to ensure FDA compliance even as your AI/ML systems evolve in real-time.
Key Takeaways:
-
- Navigate the regulatory landscape for AI/ML in healthcare.
- Understand the gap between FDA-approved versions and post-deployment software updates.
- Learn actionable steps to align your AI/ML innovations with evolving FDA requirements.
Stay ahead of the curve in the rapidly changing world of AI/ML and FDA compliance. Ensure your technology not only pushes boundaries but also meets regulatory standards, so you can safely and effectively bring innovative healthcare solutions to market.
Enroll Now!
Why you should attend
As the use of AI/ML in healthcare rapidly expands, navigating the complex and evolving FDA regulatory landscape has become a critical challenge.
With current guidelines not fully addressing the dynamic nature of AI/ML, now is the time to understand the FDA’s evolving approach and how to stay ahead.
This training will provide you with the knowledge and tools to ensure your AI/ML programs not only meet current FDA requirements but also prepare for upcoming changes in regulation. By attending, you will gain insight into the FDA’s future direction and learn how to successfully position your AI/ML innovations for regulatory approval.
Key Reasons to Attend:
-
- Clarify the Path to FDA Approval: Learn how to navigate the current regulatory requirements and understand why traditional frameworks don’t fully address AI/ML software.
- Prepare for Future Regulations: Gain a comprehensive overview of the FDA’s anticipated updates to AI/ML regulations and how you can proactively align your development programs.
- Practical Guidance on Submission: Understand the necessary documentation and steps required for a successful submission, drawing from recently approved De Novo applications.
- Stay Competitive: Ensure your organization is positioned to comply with future FDA regulations while continuing to innovate in the AI/ML space.
This 60-minute webinar is essential for professionals involved in AI/ML development, regulatory affairs, and compliance who want to stay ahead of the curve and avoid costly delays in the approval process.
By attending, you’ll leave with actionable strategies to overcome regulatory hurdles, ensuring that your AI/ML programs are not only innovative but also compliant with the latest FDA guidelines.
Join Now!
As the use of AI/ML in healthcare rapidly expands, navigating the complex and evolving FDA regulatory landscape has become a critical challenge.
With current guidelines not fully addressing the dynamic nature of AI/ML, now is the time to understand the FDA’s evolving approach and how to stay ahead.
This training will provide you with the knowledge and tools to ensure your AI/ML programs not only meet current FDA requirements but also prepare for upcoming changes in regulation. By attending, you will gain insight into the FDA’s future direction and learn how to successfully position your AI/ML innovations for regulatory approval.
Key Reasons to Attend:
-
- Clarify the Path to FDA Approval: Learn how to navigate the current regulatory requirements and understand why traditional frameworks don’t fully address AI/ML software.
- Prepare for Future Regulations: Gain a comprehensive overview of the FDA’s anticipated updates to AI/ML regulations and how you can proactively align your development programs.
- Practical Guidance on Submission: Understand the necessary documentation and steps required for a successful submission, drawing from recently approved De Novo applications.
- Stay Competitive: Ensure your organization is positioned to comply with future FDA regulations while continuing to innovate in the AI/ML space.
This 60-minute webinar is essential for professionals involved in AI/ML development, regulatory affairs, and compliance who want to stay ahead of the curve and avoid costly delays in the approval process.
By attending, you’ll leave with actionable strategies to overcome regulatory hurdles, ensuring that your AI/ML programs are not only innovative but also compliant with the latest FDA guidelines.
Join Now!
Areas Covered
-
- Total Product Life Cycle Approach to AI/ML Design: Understand the complete life cycle of AI/ML systems, from initial design through post-market updates, and how to integrate regulatory considerations at every stage.
- Application of FDA’s Software Pre-Cert Program to AI/ML: Learn how to apply the FDA’s Pre-Certification (Pre-Cert) Program to AI/ML software for streamlined approval processes.
- FDA Discussion Paper on AI/ML: Explore the insights from the FDA’s discussion paper on regulatory frameworks specific to AI/ML, and what it means for future approvals.
- Database Management: Master the strategies for effective database management to ensure that your AI/ML systems are supported by accurate, reliable, and compliant data.
- Quality Control (QC) of Datasets: Learn the critical steps in ensuring high-quality, validated datasets that meet FDA requirements.
- Algorithm Updating: Understand the process of safely and compliantly updating AI/ML algorithms post-deployment while maintaining regulatory adherence.
- Reference Standard Development: Gain insights into developing appropriate reference standards to benchmark and validate the performance of your AI/ML models.
- Standalone Performance Testing: Learn how to conduct performance testing on standalone AI/ML systems to demonstrate effectiveness in real-world scenarios.
- Clinical Performance Testing: Understand the requirements for clinical performance testing of AI/ML software to ensure its safety and efficacy in medical applications.
- Data Enrichment: Explore techniques for data enrichment that improve the performance and accuracy of AI/ML systems while adhering to FDA guidelines.
- Emphasis on “Explainability”: Understand the importance of AI/ML explainability, ensuring that your models are transparent and interpretable to meet both regulatory and clinical needs.
- Additional Labeling Requirements: Learn about the FDA’s additional labeling requirements specific to AI/ML software to ensure clear communication of product capabilities and limitations.
- Cybersecurity Considerations: Address the crucial aspect of cybersecurity in AI/ML to protect patient data and ensure system integrity against potential threats.
BONUS:
-
- PDF copy of the presentation handout for your future reference.
- Soft copy of the certificate of completion on request.
- Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email.
-
- Total Product Life Cycle Approach to AI/ML Design: Understand the complete life cycle of AI/ML systems, from initial design through post-market updates, and how to integrate regulatory considerations at every stage.
- Application of FDA’s Software Pre-Cert Program to AI/ML: Learn how to apply the FDA’s Pre-Certification (Pre-Cert) Program to AI/ML software for streamlined approval processes.
- FDA Discussion Paper on AI/ML: Explore the insights from the FDA’s discussion paper on regulatory frameworks specific to AI/ML, and what it means for future approvals.
- Database Management: Master the strategies for effective database management to ensure that your AI/ML systems are supported by accurate, reliable, and compliant data.
- Quality Control (QC) of Datasets: Learn the critical steps in ensuring high-quality, validated datasets that meet FDA requirements.
- Algorithm Updating: Understand the process of safely and compliantly updating AI/ML algorithms post-deployment while maintaining regulatory adherence.
- Reference Standard Development: Gain insights into developing appropriate reference standards to benchmark and validate the performance of your AI/ML models.
- Standalone Performance Testing: Learn how to conduct performance testing on standalone AI/ML systems to demonstrate effectiveness in real-world scenarios.
- Clinical Performance Testing: Understand the requirements for clinical performance testing of AI/ML software to ensure its safety and efficacy in medical applications.
- Data Enrichment: Explore techniques for data enrichment that improve the performance and accuracy of AI/ML systems while adhering to FDA guidelines.
- Emphasis on “Explainability”: Understand the importance of AI/ML explainability, ensuring that your models are transparent and interpretable to meet both regulatory and clinical needs.
- Additional Labeling Requirements: Learn about the FDA’s additional labeling requirements specific to AI/ML software to ensure clear communication of product capabilities and limitations.
- Cybersecurity Considerations: Address the crucial aspect of cybersecurity in AI/ML to protect patient data and ensure system integrity against potential threats.
BONUS:
-
- PDF copy of the presentation handout for your future reference.
- Soft copy of the certificate of completion on request.
- Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email.
Who is this course for
Everybody Benefits from Watching This. Even Better When Done as a Group!
-
- Regulatory Affairs Professionals looking to understand the evolving FDA guidelines for AI/ML and ensure compliance with minimal delays.
- Healthcare Innovators aiming to bring cutting-edge AI/ML solutions to market while navigating complex FDA approval processes.
- Medical Software Developers striving to implement safe, compliant AI/ML updates that continue learning post-deployment without breaching regulations.
- Compliance Officers who need to stay ahead of regulatory changes and protect their organization from costly non-compliance issues.
- Quality Assurance Specialists seeking to ensure that datasets and algorithms meet the highest standards for accuracy, reliability, and regulatory approval.
- Cybersecurity Experts tasked with safeguarding AI/ML systems from threats while maintaining the integrity of FDA-regulated software.
- Product Managers responsible for aligning AI/ML products with regulatory requirements and ensuring smooth FDA submissions.
- Clinical Trial Coordinators focused on demonstrating the clinical efficacy and safety of AI/ML technologies through rigorous performance testing.
- Healthcare Executives wanting to make informed decisions on AI/ML investments by understanding the regulatory landscape and future FDA trends.
Everybody Benefits from Watching This. Even Better When Done as a Group!
-
- Regulatory Affairs Professionals looking to understand the evolving FDA guidelines for AI/ML and ensure compliance with minimal delays.
- Healthcare Innovators aiming to bring cutting-edge AI/ML solutions to market while navigating complex FDA approval processes.
- Medical Software Developers striving to implement safe, compliant AI/ML updates that continue learning post-deployment without breaching regulations.
- Compliance Officers who need to stay ahead of regulatory changes and protect their organization from costly non-compliance issues.
- Quality Assurance Specialists seeking to ensure that datasets and algorithms meet the highest standards for accuracy, reliability, and regulatory approval.
- Cybersecurity Experts tasked with safeguarding AI/ML systems from threats while maintaining the integrity of FDA-regulated software.
- Product Managers responsible for aligning AI/ML products with regulatory requirements and ensuring smooth FDA submissions.
- Clinical Trial Coordinators focused on demonstrating the clinical efficacy and safety of AI/ML technologies through rigorous performance testing.
- Healthcare Executives wanting to make informed decisions on AI/ML investments by understanding the regulatory landscape and future FDA trends.
Instructor Profile
José Mora is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 30 years he has worked in the medical device and life sciences industry specializing in manufacturing, process development, tooling, and quality systems.
Prior to working full time as a consulting partner for Atzari Consulting, José served as Director of Manufacturing Engineering at Boston Scientific and as Quality Systems Manager at Stryker Orthopedics, where he introduced process performance, problem solving, and quality system methodologies. During that time he prepared a white paper on the application of lean manufacturing methods to the creation and management of controlled documents and a template for strategic deployment.
José led the launch of manufacturing at a start-up urology products company as Director of Manufacturing for UroSurge, Inc. at the University of Iowa’s business incubator park in Coralville, IA, creating a world-class medical device manufacturing operation, with JIT, Kanban systems, visual workplace and lean manufacturing practices.
José worked for 10 years at Cordis Corporation, now a Cardinal Health company, where he led the successful tooling, process development and qualification of Cordis’ first PTA (percutaneous transluminal angioplasty) catheter. His medical device experience includes surgical instruments, PTA & PTCA dilatation and guiding catheters, plastic surgery implants and tissue expanders, urology implants and devices for the treatment of incontinence, delivery systems for brachytherapy, orthopedic implants and instruments, and vascular surgery grafts and textiles.
During his time at Cordis, José managed the Maintenance and Facilities Department, taking that operation to a level rated as “tops” by the UK Department of Health and Social Services (DHSS) during one of their intensive audits. Jose managed Manufacturing Engineering as part of the Guiding Catheter Core Team of managers, a team that took the Cordis Guiding Catheter business to lead the market, bringing it up from fourth place. By introducing world-class techniques, the Guiding Catheter design and manufacturing was completely re-engineered for robust design and tooling, under Jose’s leadership.
He was also instrumental and played a leadership role in the complete re-engineering of the Tooling Control System, including design drafting, the tool shop and technical support. Wherever he has worked, he has a track record of introducing world-class methodologies such as Kepner-Tregoe, Taguchi techniques, Theory of Constraints, Lean Manufacturing, Five S (Visual Workplace), process validation to Global Harmonization Task Force standards, and similar approaches.
