Hands-On Workshops
Hands-On Workshops provide immersive experiences where you engage directly with medtech tools and technologies. Led by experts, these sessions let you test, build, and problem-solve in real time, turning knowledge into practical action.
Workshops are included with a Conference Pass or can be added à la carte to an Expo Pass.
Beyond Prototypes: Hands-On 3D Printing for Medical Device Production, Compliance, and Regulatory Submissions
Tuesday September 30, 2025 | 2 – 3:30 p.m. EST
Location: Conference Room 160B
Note: Attendees must bring laptops to participate in hands-on exercises
Master The Complete Additive Manufacturing Workflow in This Interactive 90-Minute Workshop
Dive into the practical world of 3D printing beyond basic prototyping. This hands-on workshop guides you through the entire production workflow—from initiating prints to essential post-processing techniques—equipping you with immediately applicable skills for medical device innovation.
What You'll Master:
- Complete Production Workflow: Experience the full process from digital design to finished medical device
- Technology Selection: Compare various 3D printing technologies with their specific medical applications
- Real-World Implementation: Analyze case studies demonstrating successful medical device development
- Regulatory Navigation: Special session with our Global Regulatory & Compliance Leader covering:
- Quality system integration strategie
- Compliance pathways specific to additive manufacturing
- Master file development and management
- Submission strategies for 3D-printed medical devices
- Designed For:
- R&D Engineers seeking production-grade solutions
- Product Developers exploring manufacturing alternatives
- Manufacturing Leads evaluating scalable technologies
- Regulatory Professionals navigating AM compliance requirements
- Innovation teams bridging MedTech and advanced manufacturing
Smart QMSR Readiness: Leveraging AI to Close Gaps & Strengthen Your QMS
Tuesday September 30, 2025 | 2 – 3:30 p.m. EST
Location: Conference Room 160A
Note: Attendees must bring laptops to participate in hands-on exercises
Prepare Your Quality Management System for QMSR Compliance Using AI-Powered Tools
Is your Quality Management System ready for QMSR alignment with ISO 13485? This workshop equips you with practical AI strategies to identify gaps, streamline documentation, and strengthen compliance—all using affordable, accessible tools that deliver immediate results.
Through guided exercises and hands-on examples, you'll master:
- QMSR Essentials: Critical requirements and implementation best practices
- AI-Powered Compliance: Practical demonstrations of AI tools that accelerate document reviews
- Document Optimization: Techniques for efficiently updating SOPs and quality procedures
- Risk Analysis Enhancement: AI-augmented approaches to comprehensive risk management
Who Should Attend
- Quality Professionals: QA Managers seeking efficient compliance strategies
- Regulatory Teams: RA specialists navigating changing requirements
- Leadership: Operations leaders and executives responsible for compliance oversight
- Technical Teams: R&D and Manufacturing Engineers implementing quality processes
- Facility Management: Site and Plant Managers ensuring facility-wide compliance
- Startups: Early-stage companies establishing compliant systems from the ground up
Whether preparing for an upcoming audit or completely overhauling your QMS to meet 2026 requirements, you'll leave with immediately applicable AI techniques to strengthen your quality management system and ensure QMSR readiness.
Designing With Humans In Mind - A Hands-On Workshop On Human Factors In Product Development
Wednesday October 1, 2025 | 2 – 3:30 p.m. EST1
Location: Conference Room 160A
Note: Attendees must bring laptops to participate in hands-on exercises
Transform Your Approach to Human Factors Engineering
Discover how integrating human factors throughout your product development cycle not only satisfies regulatory requirements but creates safer, more intuitive medical devices. This interactive workshop provides hands-on experience with techniques that satisfy increasing FDA and international scrutiny while improving user outcomes.
What You'll Experience:
- Participate in live usability testing scenarios that reveal common pitfalls and solutions
- Conduct collaborative risk assessments identifying use-related hazards often missed in traditional approaches
- Develop practical mitigation strategies that satisfy regulatory expectations
- Map human factors insights into comprehensive lifecycle risk management plans
- Navigate FDA expectations for human factors submissions and validation requirements
Special Focus: Combination Products
Explore the unique challenges where drug-device interactions create complex human factors considerations, requiring specialized approaches to ensure patient safety and regulatory compliance.
Who Should Attend
- Human Factors Engineers seeking to enhance testing methodologies
- R&D and Product Development Teams integrating usability earlier in design
- Regulatory Affairs Professionals preparing human factors submissions
- Risk Management Specialists connecting use-related hazards to broader risk strategies
- QA/Compliance Leaders ensuring human factors documentation meets requirements
- Combination Product Teams navigating complex drug-device interactions
Whether preparing for your first pre-submission meeting or refining established protocols for complex devices, you'll leave with practical tools and hands-on experience to design products that satisfy both users and regulators.
From Concept to Deployment —
Building AI Models for MedTech Imaging
Wednesday October 1, 2025 | 2 – 3:30 p.m. EST
Location: Conference Room 160B
Note: Attendees must bring laptops to participate in hands-on exercises
Transform Your Untapped Imaging Data into Powerful AI Solutions
Is your organization sitting on a goldmine of imaging data without realizing its full potential? This interactive workshop bridges the gap between raw medical imaging assets and deployable AI solutions—no data science expertise required.
During this hands-on session, you'll:
- Build a functional AI model using your laptop and Roboflow's accessible platform
- Master the complete workflow from data preparation to model deployment
- Evaluate commercial impact and ROI potential for imaging AI integration
- Develop implementation strategies tailored to your specific clinical workflows
- Navigate key considerations for bringing imaging AI solutions to market
This workshop provides immediate value for:
- Product Managers seeking to enhance product capabilities with AI
- Clinical Leaders exploring AI's potential to improve diagnostic workflows
- Executives evaluating AI investment opportunities and strategic direction
- Engineers looking for practical implementation approaches without specialized ML expertise
Your devices and clinical workflows already generate valuable imaging data every day. Join us to discover how to transform these untapped assets into powerful AI solutions that drive clinical excellence and competitive advantage.