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For early-stage medical device companies, navigating FDA regulations and ISO requirements can be complex and overwhelming. Establishing a structured, scalable Design Control framework early in development is critical to ensuring regulatory success, avoiding costly delays, and maintaining compliance with evolving global standards. Join Jennifer Mascioli-Tudor, MBA, CQA, Founder & CEO of JMT Compliance Consulting, Travis Morgan, an expert in medical device product development, and Justin Dierking, Co-Founder of myQMS.ai, for an insightful webinar where we’ll break down the fundamentals of Design Control and discuss how technology is driving QMS efficiency and regulatory agility. What You’ll Learn: ✅ Mastering Design Control & Risk Management Requirements: Gain a clear understanding of FDA Design Control regulations (21 CFR Part 820.30) and how to integrate ISO 14971 risk management principles to ensure product safety, effectiveness, and compliance throughout the device lifecycle. ✅ Navigating the Changing Regulatory Landscape: Stay ahead of evolving regulatory expectations, including the FDA’s transition to QMSR, the increasing role of AI, cybersecurity, and digital health regulations, and strategies to maintain compliance in a fast-changing environment. ✅ Practical Insights & Best Practices: Gain real-world insights into integrating Design Control into product development, overcoming common compliance challenges, and ensuring efficiency without sacrificing innovation. ✅ Leveraging AI Technology to Enhance QMS Efficiency & Compliance: Discover how emerging tools, automation, and AI-driven solutions are transforming QMS processes, improving traceability and risk management, and driving efficiency in regulatory compliance. Meet the Speakers! ✨Jennifer Mascioli-Tudor: https://www.linkedin.com/in/jennifermascioli/ ✨Travis Morgan: https://www.linkedin.com/in/morgantravis/ ✨Justin Dierking: https://www.linkedin.com/in/justin-dierking-136a97/