Evolving regulatory requirements and AI capabilities are reshaping quality management in the medical device industry. With increasing focus on compliance, traceability and patient safety, organizations must modernize their Quality Management Systems (QMS) to align with QMSR expectations and digital transformation trends. This webinar explores how medical device organizations can prepare for QMSR while building more connected, efficient and risk-aware quality operations.
This session highlights how AI is moving beyond hype to deliver practical value across quality processes, including risk management, complaint handling, audits and CAPA. It emphasizes that AI does not replace quality professionals but enhances their ability to make faster, more informed and more consistent decisions.
Attendees will gain insight into how integrated, AI-enabled eQMS platforms can improve compliance, reduce inefficiencies caused by disconnected systems and strengthen overall product quality. The presentation also explores the role of AI agents as digital assistants that automate routine tasks while enabling proactive risk identification and continuous improvement.
Ultimately, the webinar provides a roadmap for medical device organizations to successfully navigate the intersection of regulatory change and AI innovation, ensuring they remain compliant, competitive and patient-focused in a rapidly evolving landscape.
Furthermore, this webinar will help medical device organizations stay ahead of regulatory changes and FDA expectations while supporting the transition to digital, connected quality ecosystems. Attendees will learn how modern quality approaches can enable stronger risk management, patient safety and product quality, as well as provide a practical path to turn AI into a competitive advantage and a compliance asset.
Register for this webinar to learn how QMSR readiness and AI-enabled quality management can help medical device organizations improve compliance, efficiency and patient safety.
Speaker
Dr. Joseph (Joe) DeFeo, Chief Quality & Advocacy Officer, ComplianceQuest
With more than 30 years of distinguished leadership as CEO of the Juran Institute, the globally recognized authority in quality management and operational excellence. Joe succeeded the legendary Dr. Joseph M. Juran, the company’s founder, who is widely regarded as the architect of modern Quality Management. He was the originator of Quality by Design (QbD), the Pareto Principle, and the Quality Trilogy. Joe is an acclaimed author of the iconic Juran’s Quality Management Handbook: The Guide to Performance Excellence, considered a definitive resource in the field.
In 2025, Joe joined ComplianceQuest as Chief Quality & Advocacy Officer (CQAO), bringing his deep expertise and a strategic approach to achieving quality leadership to the organization. ComplianceQuest, an AI-driven technology company, was recently recognized as the top leader in the Gartner Magic Quadrant for AI-enabled QMS systems.
In this pivotal role, Joe partners closely with the CQ Leadership Team to guide and execute the company’s dual mission: driving operational excellence internally and advancing market advocacy for quality leadership externally. His expertise ensures that ComplianceQuest’s products, services, and processes continually exceed global quality standards, while strengthening customer trust and reinforcing the company’s reputation for reliability.
Joe is dedicated to empowering organizations through education, leadership development, and strategic guidance. He has helped leaders worldwide implement enterprise-wide quality management systems that drive measurable business success. His influence extends beyond management principles—Joe also cultivates high-level customer relationships, serving as a trusted executive presence in key engagements. By collaborating with sales, customer success, and marketing teams, he helps ensure client success and advances ComplianceQuest’s commitment to excellence.
Who Should Attend?
This webinar will appeal to:
- Medical Device Quality and Regulatory professionals
- QMS and Compliance leaders
- RA/QA Directors and Executives
- Digital Transformation and IT leaders in regulated industries
What You Will Learn
This webinar will appeal to:
- How QMSR impacts modern quality management practices
- Where AI delivers real, compliant value in medical device QMS
- How to identify high-impact AI use cases across quality processes
- The role of AI agents and integrated eQMS platforms in improving efficiency and compliance
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1. QMSR is driving the need for modernization
- Medical device organizations must evolve QMS to meet:
- Greater regulatory alignment and traceability
- Increased scrutiny on risk, safety, and compliance
- Digital transformation is essential to keep up with regulatory expectations.
2. AI is enhancing—not replacing—quality teams
- AI supports:
- Faster decision-making
- Improved consistency in processes
- Reduced manual workload
- Human expertise remains critical for oversight and compliance.
3. Connected eQMS is the foundation for compliance and AI success
- AI effectiveness depends on:
- Integrated systems
- Accessible, high-quality data
- End-to-end process visibility
- Disconnected systems create inefficiencies and compliance risks.
4. AI use cases are delivering measurable value in QMS
- Practical applications include:
- Complaint and adverse event analysis
- Automated audit insights and documentation
- Risk prediction and prioritization
- Nonconformance and CAPA management
- These use cases drive improvements in quality, cost, and speed.
5. AI agents are transforming quality operations
- AI-powered digital assistants can:
- Automate repetitive QMS tasks
- Identify trends and recurring issues
- Enhance compliance through real-time insights
- They enable teams to focus on higher-value work.
6. Measurable outcomes demonstrate AI’s impact
- Organizations adopting AI-enabled QMS see:
- Reduced complaints and audit findings
- Faster training and onboarding
- Lower cost of quality
- Higher customer satisfaction and compliance performance
7. Strategic adoption is critical
- Success requires:
- Clear use cases tied to regulatory needs
- Strong data infrastructure
- Continuous learning and adaptation
- AI must align with both business goals and regulatory requirements.
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Xtalks Partner
ComplianceQuest
ComplianceQuest is the #1 AI-Powered Quality, Risk, and Compliance (QRC) platform that connects product, manufacturing, people, and partner quality in a single system. Built on Salesforce, the platform delivers end-to-end visibility, AI-driven intelligence, and enterprise-scale execution, enabling organizations to prevent risk, ensure compliance by design, and turn quality into a driver of growth.
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