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Invitation Only
Invitation Only
Separate Ticket or Advanced Registration Required
Separate Ticket or Advanced Registration Required
Repeat Solutions Circle
Repeat Solutions Circle

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  • Monday, Oct 6th
    8:30 AM - 4:00 PM EST
    A Lean System to Report Supply Interruptions and Discontinuations (Article 10a in EU, RoW)
    Workshop Leader: Lawrence Yeh, BASc – AKRA TEAM
    Workshop Presenter: Erik R. Vollebregt – Axon Lawyers
    Workshop Presenter: Anja Wiersma, PhD – mi-CE consultancy
    Workshop Presenter: Francis Dekker, PhD – Thermo Fisher Scientific
    Devices (includes Medical Devices & In Vitro Diagnostics)
  • Monday, Oct 6th
    8:30 AM - 4:00 PM EST
    Survivor: The FDA 510(k) Program Edition (Day 1 of 2)
    Workshop Leader: Mark E. DuVal, JD, FRAPS – DuVal & Associates, P.A.
    Workshop Presenter: Lisa L. Pritchard, BSEEE – DuVal & Associates, P.A.
    Workshop Presenter: Kathy Herzog, BSME – DuVal & Associates, P.A.
    Workshop Presenter: Allison Komiyama, PhD, RAC, FRAPS – RQM+
    Workshop Presenter: Dongbo Wang, PhD – Intuitive
    Devices (includes Medical Devices & In Vitro Diagnostics)
  • Tuesday, Oct 7th
    8:30 AM - 4:00 PM EST
    Change Management on MDR and IVDR
    Workshop Leader: Anna Spehl – AKRA Team
    Workshop Presenter: Glenda Marsh – Johnson & Johnson Medtech
    Workshop Presenter: Poornima Bedi – Medtronic
    Workshop Presenter: Tom Patten, n/a – GMED Certification Division
    Devices (includes Medical Devices & In Vitro Diagnostics)
  • Tuesday, Oct 7th
    8:30 AM - 4:00 PM EST
    How to Prepare a Robust Biocompatibility Assessment
    Workshop Leader: Amra Racic – Veeva MedTech
    Workshop Presenter: William Mycroft
    Workshop Presenter: Robert Allen
    Workshop Presenter: Danny Oseid
    Devices (includes Medical Devices & In Vitro Diagnostics)
  • Tuesday, Oct 7th
    8:30 AM - 4:00 PM EST
    Survivor: The FDA 510(k) Program Edition (Day 2 or 2)
    Workshop Leader: Mark E. DuVal, JD, FRAPS – DuVal & Associates, P.A.
    Workshop Presenter: Lisa L. Pritchard, BSEEE – DuVal & Associates, P.A.
    Workshop Presenter: Kathy Herzog, BSME – DuVal & Associates, P.A.
    Workshop Presenter: Allison Komiyama, PhD, RAC, FRAPS – RQM+
    Workshop Presenter: Dongbo Wang, PhD – Intuitive
    Devices (includes Medical Devices & In Vitro Diagnostics)
  • Wednesday, Oct 8th
    9:15 AM - 10:30 AM EST
    Advertisement & Promotional Material
    Moderator: Amar Chanani, RAC: Devices, PMP, CMQ/OE, CSQE, CRE, CQE, CQA – QARA Solutions, LLC
    Presenter: Robert Bilkovski, MD, MBA – RNB Ventures Consulting
    Presenter: Erin Rowley
    Presenter: Monika Bhatt – Siemens Healthineers
    Devices (includes Medical Devices & In Vitro Diagnostics)
  • Wednesday, Oct 8th
    9:15 AM - 10:30 AM EST
    EU MDR Kick-off: “The Latest and Greatest News from Europe”
    Presenter: Sabina L. Hoekstra-van den Bosch, PharmD, FRAPS – TÜV SÜD
    Presenter: Gert W. Bos, PhD FRAPS – QServe Group
    Presenter: Bassil Akra, PhD – Akra Team
    Presenter: Ehab Amen – GMED North America
    Presenter: Monica Wilkins – Abbott
    Devices (includes Medical Devices & In Vitro Diagnostics)
  • Wednesday, Oct 8th
    9:15 AM - 10:30 AM EST
    US & EU Perspectives on AI Regulation
    Presenter: Suchitra (Suchi) Basu, PhD – J&J MedTech
    Devices (includes Medical Devices & In Vitro Diagnostics)
  • Wednesday, Oct 8th
    11:15 AM - 11:45 AM EST
    (repeat) Tips for successful 10-day Conference Call with FDA
    Facilitator: Samhitha Mohan, MS, RAC – BD - Becton, Dickinson and Company
    Devices (includes Medical Devices & In Vitro Diagnostics)Solutions Circle
  • Wednesday, Oct 8th
    11:55 AM - 12:25 PM EST
    State Licensing for Medical Device Companies: How Does it Apply to Me?
    Devices (includes Medical Devices & In Vitro Diagnostics)Solutions Circle
  • Wednesday, Oct 8th
    1:00 PM - 2:00 PM EST
    MDUFA Program Explained
    Moderator: Amra Racic – Veeva MedTech
    Presenter: Philip Desjardins, JD – Arnold & Porter
    Devices (includes Medical Devices & In Vitro Diagnostics)
  • Wednesday, Oct 8th
    1:00 PM - 2:00 PM EST
    Modeling the Future: Regulatory Perspectives on In Silico Tools for Medical Devices
    Session Leader: Surash Surash, FRCS (Neuro.Surg), MD, LLM – TÜV SÜD
    Presenter: Samhitha Mohan, MS, RAC – BD - Becton, Dickinson and Company
    Presenter: Marc Horner, PhD – Ansys
    Presenter: Martha De Cunha Maluf-Burgman, MBA – Edwards LifeSciences
    Devices (includes Medical Devices & In Vitro Diagnostics)
  • Wednesday, Oct 8th
    1:00 PM - 2:00 PM EST
    Translating the AI Regulatory Landscape to Quality Management Systems: EU MDR, ISO/IEC 42001, and Beyond
    Presenter: Attrayee Chakraborty, MSc., MS, CQSP – Analog Devices
    Presenter: Geethapriya Setty, MS, MBA, RAC – Medical Device
    Devices (includes Medical Devices & In Vitro Diagnostics)
  • Wednesday, Oct 8th
    2:15 PM - 3:15 PM EST
    China Regulatory Landscape: Key Changes in 2025
    Presenter: Grace F. Palma, MBA – China Med Device, LLC
    Presenter: Qianqian Zhu, MBA,LLM,RAC – Intuitive Surgical, Inc.
    Presenter: Linda He – Stryker Neurovascular International
    Devices (includes Medical Devices & In Vitro Diagnostics)
  • Wednesday, Oct 8th
    2:15 PM - 3:15 PM EST
    Decoding and Understanding Artificial Intelligence (AI) - EU AI implementation
    Presenter: Abhineet Johri – Siemens healthineers
    Presenter: Leo Hovestadt – Elekta
    Devices (includes Medical Devices & In Vitro Diagnostics)
  • Wednesday, Oct 8th
    2:15 PM - 3:15 PM EST
    Latest Developments in PFAS
    Presenter: Catherine V. Moustakas – DEKRA Certification
    Presenter: Lindsey Zocolo – Edwards Lifesciences
    Devices (includes Medical Devices & In Vitro Diagnostics)
  • Wednesday, Oct 8th
    3:20 PM - 3:50 PM EST
    (repeat) Early Innovation: Navigating the Tech Transfer Journey from Academia to Industry
    Facilitator: Frederike S. Brühschwein-Mandic – confinis ag
    Devices (includes Medical Devices & In Vitro Diagnostics)Solutions Circle
  • Wednesday, Oct 8th
    3:55 PM - 4:25 PM EST
    (repeat) Navigating Novel Risks in AI/ML/LLM-Enabled Medical Devices: Regulatory and Lifecycle Risk Management Strategies
    Facilitator: Yu Zhao, MBA, MS – Bridging Consulting LLC
    Devices (includes Medical Devices & In Vitro Diagnostics)Solutions Circle
  • Wednesday, Oct 8th
    4:30 PM - 5:30 PM EST
    AI in Medical Devices: From Regulatory Frameworks to Global Market Readiness
    Devices (includes Medical Devices & In Vitro Diagnostics)
  • Wednesday, Oct 8th
    4:30 PM - 5:30 PM EST
    Environmental and EcoDesign requirements in Europe and beyond
    Presenter: Darren J. Thain – Smith+Nephew
    Presenter: Erik R. Vollebregt – Axon Lawyers
    Devices (includes Medical Devices & In Vitro Diagnostics)
  • Wednesday, Oct 8th
    4:30 PM - 5:30 PM EST
    Rethinking Regulatory Strategy: De-risking Submissions and Addressing Payer Needs with Comprehensive Evidence Planning
    Presenter: Chris Lyle, MS – DuVal & Associates
    Devices (includes Medical Devices & In Vitro Diagnostics)
  • Thursday, Oct 9th
    9:15 AM - 10:30 AM EST
    EU Notified Body Forum: Tips and tricks for effective MDR/IVDR implementation
    Moderator: Bassil Akra, PhD – Akra Team
    Presenter: Sabina L. Hoekstra-van den Bosch, PharmD, FRAPS – TÜV SÜD
    Presenter: Alexey Shiryaev, PhD – DNV
    Presenter: Suzanne Halliday, DPhil, FRAPS – BSI
    Presenter: Gert W. Bos, PhD FRAPS – QServe Group
    Devices (includes Medical Devices & In Vitro Diagnostics)
  • Thursday, Oct 9th
    9:15 AM - 10:30 AM EST
    Navigating Global Regulatory Pathways for Orphan Medical Devices
    Moderator: Matthias Fink – AKRA TEAM Inc.
    Presenter: Bianca Lutters – QServe Consultancy B.V.
    Presenter: Richard G. Holborow, n.a. – BSI
    Presenter: Alberto Ganan, PhD – European Medicines Agency
    Devices (includes Medical Devices & In Vitro Diagnostics)
  • Thursday, Oct 9th
    9:15 AM - 10:30 AM EST
    US Regulatory Policy in the New Era and Impact to MedTech Industry
    Presenter: Amra Racic – Veeva MedTech
    Devices (includes Medical Devices & In Vitro Diagnostics)
  • Thursday, Oct 9th
    10:35 AM - 11:05 AM EST
    Quality Culture: How to Make Meaningful Impact as an Early-Career Professional
    Facilitator: Attrayee Chakraborty, MSc., MS, CQSP – Analog Devices
    Devices (includes Medical Devices & In Vitro Diagnostics)Solutions Circle
  • Thursday, Oct 9th
    11:15 AM - 11:45 AM EST
    (repeat) Tips for successful 10-day Conference Call with FDA
    Facilitator: Samhitha Mohan, MS, RAC – BD - Becton, Dickinson and Company
    Devices (includes Medical Devices & In Vitro Diagnostics)Solutions Circle
  • Thursday, Oct 9th
    1:00 PM - 2:00 PM EST
    A Case Study on Health Equity Through the Lens of Pulse Oximetry
    Presenter: Samir Ibrahim, PhD, MBA, RAC – Medtronic
    Presenter: Neerav Parikh – Medtronic
    Moderator: Amra Racic – Veeva MedTech
    Devices (includes Medical Devices & In Vitro Diagnostics)
  • Thursday, Oct 9th
    1:00 PM - 2:00 PM EST
    Practical Tips for Speeding Up Postmarket Innovation with Predetermined Change Control Plans (PCCPs) Beyond AI/ML
    Moderator: Yu Zhao, MBA, MS – Bridging Consulting LLC
    Panelist: Kelliann Payne – Hogan Lovells
    Panelist: Alex Cadotte, PhD – MCRA, an IQVIA Company
    Panelist: Angie Noah, PhD – Medtronic
    Panelist: Alexander Chan, PhD – Beacon Biosignals
    Devices (includes Medical Devices & In Vitro Diagnostics)
  • Thursday, Oct 9th
    1:00 PM - 2:00 PM EST
    Structured Dialogues: 10 Effective Topics to Engage With Your Notified Body
    Presenter: Gert W. Bos, PhD FRAPS – QServe Group
    Presenter: Sabina L. Hoekstra-van den Bosch, PharmD, FRAPS – TÜV SÜD
    Devices (includes Medical Devices & In Vitro Diagnostics)
  • Thursday, Oct 9th
    2:05 PM - 2:35 PM EST
    (repeat) Early Innovation: Navigating the Tech Transfer Journey from Academia to Industry
    Facilitator: Frederike S. Brühschwein-Mandic – confinis ag
    Devices (includes Medical Devices & In Vitro Diagnostics)Solutions Circle
  • Thursday, Oct 9th
    2:40 PM - 3:10 PM EST
    (repeat) Navigating Novel Risks in AI/ML/LLM-Enabled Medical Devices: Regulatory and Lifecycle Risk Management Strategies
    Facilitator: Yu Zhao, MBA, MS – Bridging Consulting LLC
    Devices (includes Medical Devices & In Vitro Diagnostics)Solutions Circle
  • Thursday, Oct 9th
    3:15 PM - 4:15 PM EST
    Cybersecurity Regulations and Policy: FDA and Beyond
    Presenter: Michelle Jump, RAC, MS – MedSec LLC
    Presenter: Matthew Hazelett – MedSec
    Devices (includes Medical Devices & In Vitro Diagnostics)
  • Thursday, Oct 9th
    3:15 PM - 4:15 PM EST
    Mastering EUDAMED: Current Framework and Implementation Strategies
    Presenter: Francis Dekker, PhD – Thermo Fisher Scientific
    Presenter: Richard Houlihan, MBA BSc – EirMed Ltd
    Presenter: Sandra Ferretti, MA – Obelis
    Devices (includes Medical Devices & In Vitro Diagnostics)
  • Thursday, Oct 9th
    3:15 PM - 4:15 PM EST
    Middle East Reliance
    Devices (includes Medical Devices & In Vitro Diagnostics)
  • Thursday, Oct 9th
    4:30 PM - 5:30 PM EST
    Conformity Assessment of Class D Devices & EURL Implementation: Progress and Challenges One Year On
    Presenter: Marta Carnielli – TÜV SÜD
    Presenter: Tom Patten, n/a – GMED Certification Division
    Presenter: Alex Laan – BSI BV
    Presenter: Jennifer Rosendahl, PhD. – RISE
    Devices (includes Medical Devices & In Vitro Diagnostics)
  • Thursday, Oct 9th
    4:30 PM - 5:30 PM EST
    Policy Updates UK & Switzerland
    Devices (includes Medical Devices & In Vitro Diagnostics)
  • Thursday, Oct 9th
    4:30 PM - 5:30 PM EST
    QSR to QMSR Shift: Best Practices, Pitfalls & Compliance Strategies
    Devices (includes Medical Devices & In Vitro Diagnostics)