• Implementing the FDA's Accreditation Scheme for Conformity Assessment (ASCA)
  Shireen Fotelargias, MS, Senior Policy Analyst, FDA
  Jennifer Coble, MPM, Regulatory Policy Analyst, FDA
• Restrictions on PFAS and the Implications for Medical Device Manufacturing and Device Supply Chains
  Tammy Beckham, Associate Office Director, FDA
  Khatereh Calleja, JD, Senior Vice President and Department Deputy, Technology and Regulatory, AdvaMed
  Ed Margerrison, Director Office of Science and Engineering, FDA
  Mike Hoffman, Program Lead, Medical Device Shortages Program, Office of Product Evaluation and Quality, FDA
  Aine Smalley, Senior Regulatory Advisor, Medtronic
• Navigating the Maze of Medical Device Standards
  Janet Prust, Principal, St. Croix Standards Consulting, LLC
  Joe Lewelling, Vice President of Industry, AAMI
• Implementation of AI in Healthcare
  Matthew Diamond, MD, PhD, Chief Medical Officer, Digital Health Center of Excellence, FDA
  Pat Baird, Sr. Regulatory Specialist, Philips
  Dr. Aditya Kale, BMedSci, MBChB, Clinical Research Fellow in AI and Digital Health, University Hospital Birmingham UK
  Jeffery Smith, Deputy Director, Certification & Testing Division, Office of the National Coordinator for Health Information Technology
  Christopher Longhurst, MD, MS, Chief Medical Officer and Chief Digital Officer, UC San Diego Health
  Linda Fischetti, Director, Health and Society Innovation Center, The MITRE Corporation

Opening Keynote Speaker: Consensus Standards: Speeding Patient Access to Medical Devices
Jeffrey Shuren, MD, JD, Director, Center for Devices and Radiological Health (CDRH) at FDA

21 CFR 820 Amendment Final Rule
Keisha Thomas, Associate Director for Compliance and Quality, FDA/CDRH
Kimberly Lewandowski-Walker, Regulatory Officer, FDA

Presentation Reactor Panel
Mario Wijker, Corporate VP QA/RA, Bio-Rad Laboratories, Inc.
Nicole Taylor-Smith, Vice President, Global Head of Regulatory Science and Policy, Philips
Keisha Thomas, Supervisory Consumer Safety, FDA
Kimberly Lewandowski-Walker, Regulatory Officer, FDA

Update on FDA's Case for Quality
Francisco Vicenty, Consumer Safety Officer, FDA

• Biocompatibility Testing of Medical Devices–Update on ISO 10993 and FDA Guidance
  Jennifer Goode, Biomedical Engineer, FDA
• Transitioning from 21 CFR 820 to ISO 13485–Part 1
  Jack Ward, President, Ward Sciences and Consulting LLC
  Tina Krenc, Owner/Principal, KTA Compliance Consulting
  Aaron Snyder, Vice President of Quality Assurance, Allotex
  
• Update on Coming Revision of Human Factors Standards–HE75 and IEC 62366
  Molly Story, Principal/Owner, Human Spectrum Design, LLC
  Mary Beth Privitera, PhD, Professor, University of Cincinnati
• Global Perspectives on the Current and Future State of EO Sterilization
  Brian McEvoy, Senior Director Global Technologies, STERIS Corporation
  Lisa Simone, Health Scientist, FDA
  Scott Weiss, Alcon
  

• Update on Medical Device Software Standards (IEC 62304, TIR 45)
  Patricia Krantz-Zuppan, Software Standardization and Regulatory Policy Advocacy, Medtronic
• Transitioning from 21 CFR 820 to ISO 13485–Part 2
  Jack Ward, President, Ward Sciences and Consulting LLC
  Tina Krenc, Owner/Principal, KTA Compliance Consulting
  Aaron Snyder, Vice President of Quality Assurance, Allotex
• How to Use FDA's e-STAR
  Patrick Macatangga, MS, Tools and Template Engineer, FDA
  Lili Duan, Chemist, PhD, FDA
• Human Factors Engineering for Combination Products
  Molly Story, Principal/Owner, Human Spectrum Design, LLC
• Practical Approaches in Transitioning Radiation Sterilization Modalities
  Martell Winters, RM/SM (NRCM), CISS-RAD, Scientific Competency Expert, Nelson Labs
  Ryan Ortega, Regulatory Policy Advisor, Office of Product Evaluation and Quality, FDA/CDRH

Addressing the Total Product Lifecycle: Sustainability, Supply Chain, Resilience, and Other Issues and Opportunities
Linda Ricci, Deputy Office Director, FDA
Tammy Beckham, Associate Office Director, FDA
Lena Cordie-Bancroft, Sector Lead-Medical Devices, BSI Healthcare

Foundation Courses - Part 1- Pre-registration Required

• Industrial Sterilization
  Gerry O'Dell, Owner/President, Gerry O'Dell Consulting
  Clark Houghtling, Vice President of Business Development & Technical Affairs, Cosmed Group, Inc.
• Quality Systems
  Margaret Koga Ward, Independent Consultant, a Notified Body Auditor
  Aaron Snyder, Vice President of Quality Assurance, Allotex
• Human Factors
  Rita Lin, Director of Human Factors Engineering, Agilis
  MaryBeth Privitera, PhD, FIDSA, Profess of Biomedical Engineering Specializing in Medical Device Design/Human Factors, University of Cincinnati

• Digital Health and Predetermined Change Control Plans for AI-Enabled Devices (and Implications for Other Medical Devices)
  Jessica Paulsen, OPEQ Digital Health Associate Director, FDA
  Cassie Scherer, JD, Senior Director of U.S. Regulatory and Global Digital Health Policy, Medtronic
• FDA Standards and Conformance Program Updates
  Terry Woods, Ph.D., Director, Standards and Conformity Assessment Division, FDA
  Gail Rodriguez, Senior Policy Advisor, FDA
• Upcoming Revision of IEC 60601 Series
  Brodie Pedersen, BS, EE, Chief Regulatory Officer, Borderless MedDev LLC
• Fostering Innovation and Acceptance: Novel Sterilization Modalities
  David Opie, Noxilizer
  Dr. Mohamad Al-Sheikhly, PhD, University of Maryland

• FDA ASCA Program
  Eric Franca, Ph.D., ASCA Team Lead, FDA
• Update on New and Revised Labelling Standards (ISO 15223, ISO 20417)
  Lena Cordie-Bancroft, Sector Lead-Medical Devices, BSI Healthcare
  David Osborn, AAMIF, BEE, MEE, Sr Manager of Global Regulations & Standards, Philips
• New Cybersecurity Standards and Shared Responsibility (including ANSI/AAMI SW96:2023)
  Michelle Jump, CEO, MedSec
• Compatibility of Materials with Sterilization: What? Why? and Where? (and What’s Next!)
  Jami McLaren, Principal Sterilization Scientist, Boston Scientific
  

The FDA/CDRH's Advancing Health Equity Strategic Priorities and Current Industry Efforts
Jacqueline Cunkelman, Supervisor Physician, FDA
DeChane Dorsey, Executive Director, AdvaMed

Addressing Patient Preference in Developing Medical Devices
Olufemi Babalola, Economist, FDA
Michelle Tarver, MD, PhD, Deputy Center Director, Chief Transformation Officer, FDA/CDRH

• Industrial Sterilization
  Gerry O'Dell, Owner/President, Gerry O'Dell Consulting
  Clark Houghtling, Vice President of Business Development & Technical Affairs, Cosmed Group, Inc.
• Quality Systems
  Margaret Koga Ward, Independent Consultant, a Notified Body Auditor
  Aaron Snyder, Vice President of Quality Assurance, Allotex
• Human Factors
  Rita Lin, Director of Human Factors Engineering, Agilis
  MaryBeth Privitera, PhD, FIDSA, Profess of Biomedical Engineering Specializing in Medical Device Design/Human Factors, University of Cincinnati

• Making Standards Regulatory-Ready
  Gail Rodriguez, Senior Policy, FDA
  Terry Woods, Ph.D., Director, Standards and Conformity Assessment Division, FDA
  Matthew Williams, MBA, LSSBB, Vice President, Standards, AAMI
• In-Depth Review of ISO 10993-17:2023, Biological Evaluation of Medical Devices–Part 17: Toxicological Risk Assessment of Medical Device Constituents
  Ronald Brown, Owner & Principal Toxicologist, Risk Science Consortium, LLC
  
• Contamination Control and Cleaning Issues for Capital Patient Care Equipment and Home Health Care Devices
  Alpa Patel, Director of Scientific Improvement and Reprocessing Expert, Nelson Labs
  
• Quality Systems for Combinations Products (Revised AAMI TIR48)
  Susan Neadle, Principal Consultant, Combination Products Consulting Services LLC
  Kent Abrahamson, Director for Combination Product Development, AbbVie
  

• International Standardization of Medical Device Maintenance and Repair
  Scott Trevino, Senior VP-Product Management and Solutions, TRIMEDX
  Katelyn Bittleman, PhD, Policy Analyst, FDA/CDRH
• Utilizing Artificial Intelligence in the Quality Management System
  Mario Wijker, Corporate VP QA/RA, Bio-Rad Laboratories, Inc.
  Francisco Vicenty, Consumer Safety Officer, FDA
  
• Challenges and Considerations for Maintaining Packaging Integrity for Device Sterility from Manufacturing to Use
  Jennifer Benolken, MDM & Regulatory Representative, DuPont
• Pulse Oximeters
  Sandy Weininger, Electrical Engineer, FDA
  Julian Goldman, MD, Medical Director, Biomedical Engineering, Mass General Brigham
  Anura Fernando, Global Head of Medical Device Security Patient Monitoring, UL
  Samuel Ajizian, MD, Chief Medical Officer, Patient Monitoring, Medtronic
  

Update on Regulatory Change in the EU and UK
Graeme Tunbridge, Senior Vice President Global Regulatory and Quality, Medical Devices, BSI
Joseph Gatewood, Vice President, Global Strategy, AdvaMed

Update on the EU and UK Harmonization
Richard Bancroft, Senior Director, Scientific, STERIS

• Industrial Sterilization
  Gerry O'Dell, Owner/President, Gerry O'Dell Consulting
  Clark Houghtling, Vice President of Business Development & Technical Affairs, Cosmed Group, Inc.
• Quality Systems
  Margaret Koga Ward, Independent Consultant, a Notified Body Auditor
  Aaron Snyder, Vice President of Quality Assurance, Allotex
• Human Factors
  Rita Lin, Director of Human Factors Engineering, Agilis
  MaryBeth Privitera, PhD, FIDSA, Profess of Biomedical Engineering Specializing in Medical Device Design/Human Factors, University of Cincinnati

• Addressing Circular Economy Requirements in Standards
  Lena Cordie-Bancroft, Sector Lead-Medical Devices, BSI Healthcare
  Patricia Krantz-Zuppan, Software Standardization and Regulatory Policy Advocacy, Medtronic
• Addressing Data Bias Management for Medical Devices (Spotlight on ML Devices and the Proposed AAMI Standard)
  Pat Baird, Sr Regulatory Specialist, Philips
  Tina Krenc, Owner/Principal, KTA Compliance Consulting
• IMDRF Update
  Ken Cavanaugh, Supervisory Biomedical Engineering, FDA
  Nicole Taylor-Smith, Vice President, Global Head of Regulatory Science and Policy, Philips
• Developing Meaningful and Practical IFUs for Medical Device Processing
  Nupur Jain, Director, Device Reprocessing & Sterilization, Intuitive Surgical Inc.
  Ralph Basile, Vice President Marketing & Regulatory Affairs, Healthmark Industries Company Inc
  Damien Berg, Vice President of Strategic Initiatives, HSPA
  Steve Turtil, Biologist, FDA
  

• Use of Real-World Evidence to Support Medical Device Effectiveness and Safety
  Hajira Ahmad, Policy Analyst, FDA/OCEA
• New and Coming Standards for AI/ML in Medical Devices
  Pat Baird, Sr Regulatory Specialist, Philips
  Patricia Krantz-Zuppan, Software Standardization and Regulatory Policy Advocacy, Medtronic
• Medical Device Single Audit Program
  Neil Mafnas, Program Management, FDA
• Practical Approaches for Validation of Cleaning Processes
  Terra Kremer, Director of Microbiological Quality, Johnson & Johnson

FDA New Rules/Recommendations for Cybersecurity
Jessica Wilkerson, Lead Cybersecurity Specialist, FDA

• Industrial Sterilization
  Gerry O'Dell, Owner/President, Gerry O'Dell Consulting
  Clark Houghtling, Vice President of Business Development & Technical Affairs, Cosmed Group, Inc.
• Quality Systems
  Margaret Koga Ward, Independent Consultant, a Notified Body Auditor
  Aaron Snyder, Vice President of Quality Assurance, Allotex
• Human Factors
  Rita Lin, Director of Human Factors Engineering, Agilis
  MaryBeth Privitera, PhD, FIDSA, Profess of Biomedical Engineering Specializing in Medical Device Design/Human Factors, University of Cincinnati

• Reducing Submission Rejections and Recalls with Software Standards
  Mike Russell, Partner, SoftwareCPR
  Dave Nelson, Associate Software Director, Boston Scientific
  Jeremy Jensen, SQE Fellow, Boston Scientific
• The EU Artificial Intelligence Act and its Implications for Medical Device Manufacturers
  Graeme Tunbridge, Senior Vice President Global Regulatory and Quality, Medical Devices, BSI
  
• Regulatory Convergence in Saudi Arabia, the Americas and Africa
  Steven Bipes, Vice President, Global Strategy & Analysis, AdvaMed
  Abdullah Alghuraibi, MD, Regulations & Registration Support, Saudi Food and Drug Authority
  
• New Technologies for Sterilization of 3D Printed Devices
  Randy Eveland, Senior Principle Scientist, STERIS Corporation
  

• The Challenge of Implementing a Standards Management Program in a Medical Device Company
  Janet Prust, Principal, St Croix Standards Consulting LLC
  David Osborn, Sr Manager of Global Regulations & Standards, Philips
• Challenges of 3D printing of Medical Devices at the Point of Care
  
• Review of Medical Device Developments in Priority Asian Markets (China, India, Russia)
  Ashley Miller, Executive Vice President of Global Strategy and Analysis, AdvaMed
  
• At the Five Year Mark: Updates from the Kilmer Collaboration Teams
  Glenn Wright, President and CEO, Parenteral Drug Association
  Amanda Benedict, Vice President, Sterilization, AAMI