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  • Monday, Sep 16th
    8:30 AM – 4:00 PM PDT
    Artificial Intelligence knocking on your door? The upcoming Artificial Intelligence Act’s Technical Documentation Requirements and how to integrate them into a Medical Device Regulation Submission
    Location/Room: 102
    Workshop Leader: Sarah Mathew – BSI
    Presenter: Daniela Seneca, MEng – BSI
    Presenter: Kenneth Fuh, PhD – TÜV SÜD Product Service GmbH
    Preconference WorkshopDevices (includes Medical Devices and In Vitro Diagnostics)
  • Monday, Sep 16th
    8:30 AM – 4:00 PM PDT
    Survivor: The FDA 510(k) Program Edition (Day 1 of 2)
    Location/Room: 202
    Presenter: Mark E. DuVal, JD, FRAPS – DuVal & Associates, P.A.
    Presenter: Lisa L. Pritchard, BSEEE – DuVal & Associates, P.A.
    Presenter: Kathy Herzog, BSME – DuVal & Associates, P.A.
    Presenter: Allison Komiyama, PhD, RAC, FRAPS – RQM+
    Presenter: Dongbo Wang, PhD – Histosonics
    Presenter (Remote): Ken Skodacek – FDA/CDRH
    Preconference WorkshopDevices (includes Medical Devices and In Vitro Diagnostics)
  • Tuesday, Sep 17th
    8:30 AM – 4:00 PM PDT
    Basics of Regulatory Strategy for the US & EU for Devices (includes Medical Devices and In Vitro Diagnostics)
    Location/Room: 102
    Workshop Leader: Ayesha Shah – Veeva Systems
    Presenter: Josh Silverstein, PhD – Philips
    Presenter: Sabina Hoekstra, PharmD FRAPS – TÜV SÜD Medical Health Services
    Presenter (Remote): Christelle Bouygues, PharmD – EMA
    Preconference WorkshopDevices (includes Medical Devices and In Vitro Diagnostics)
  • Tuesday, Sep 17th
    8:30 AM – 4:00 PM PDT
    MDR Surveillance, Post-Certification and Re-certification Submissions to Notified Bodies: Best Practice for Manufacturers
    Location/Room: 104 B
    Workshop Leader: Purvi S. Patel, PhD CEng – BSI
    Presenter: Rachel Mead, BEng MIET – BSI
    Presenter: Vishal Thakker, MEng – BSI
    Presenter: Alexey Shiryaev, MD PhD – DNV Product Assurance AS
    Presenter: Duncan McPherson, MBBS FRCA – LNE-GMED-UK
    Preconference WorkshopDevices (includes Medical Devices and In Vitro Diagnostics)
  • Tuesday, Sep 17th
    8:30 AM – 4:00 PM PDT
    Survivor: The FDA 510(k) Program Edition (Day 2 of 2)
    Location/Room: 202
    Presenter: Mark E. DuVal, JD, FRAPS – DuVal & Associates, P.A.
    Presenter: Lisa L. Pritchard, BSEEE – DuVal & Associates, P.A.
    Presenter: Kathy Herzog, BSME – DuVal & Associates, P.A.
    Presenter: Allison Komiyama, PhD, RAC, FRAPS – RQM+
    Presenter: Dongbo Wang, PhD – Histosonics
    Presenter (Remote): Ken Skodacek – FDA/CDRH
    Preconference WorkshopDevices (includes Medical Devices and In Vitro Diagnostics)
  • Wednesday, Sep 18th
    9:15 AM – 10:30 AM PDT
    Future State of Europe
    Location/Room: 102
    Moderator: Sabina Hoekstra, PharmD FRAPS – TÜV SÜD Medical Health Services
    Moderator: Gert W. Bos, MSc, PhD and FRAPS – Qserve Group
    Presenter: Royth P. von Hahn, PhD – TÜV SÜD Product Services
    Presenter: Leo Hovestadt – Elekta
    Presenter (Remote): Flora Giorgio – European Commission
    Devices (includes Medical Devices and In Vitro Diagnostics)
  • Wednesday, Sep 18th
    9:15 AM – 10:30 AM PDT
    Standardization of Clinical Study Design
    Location/Room: 104 C
    Presenter: Bassil Akra – AKRA TEAM
    Presenter: Diane M. Legere, RN MSc APCCN – DNV Product Assurance AS
    Presenter (Remote): Danielle Giroud, MSci, MBA – MD-CLINICALS SA
    Presenter (Remote): Theodor Framke
    Devices (includes Medical Devices and In Vitro Diagnostics)
  • Wednesday, Sep 18th
    10:35 AM – 11:05 AM PDT
    Solution Circle (A): How to Prepare for a Successful FDA Q-sub
    Location/Room: Exhibit Hall: Solutions Circles Area (A)
    Facilitator: Lucy Tan – Abbott
    Exhibit Hall: Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)
  • Wednesday, Sep 18th
    10:35 AM – 11:05 AM PDT
    Solution Circle (B): Is this AI/ML Software Application a Medical device? Applying FDA Guidance Documents and On-Line Resources
    Location/Room: Exhibit Hall: Solutions Circles Area (B)
    Facilitator: Alex Friedman, PhD, RAC – Beckman Coulter
    Exhibit Hall: Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)
  • Wednesday, Sep 18th
    11:10 AM – 11:40 AM PDT
    Solution Circle (A): Evaluating the Quality of Real-World Evidence Used to Support Regulatory Decision-Making for Medical Devices
    Location/Room: Exhibit Hall: Solutions Circles Area (A)
    Facilitator: Michelle Kavin, PhD, PA-C – Johnson and Johnson
    Exhibit Hall: Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)
  • Wednesday, Sep 18th
    11:10 AM – 11:40 AM PDT
    Solution Circle (B): Strategies on Tackling Clinical Data Gaps Between Different Designs of Medical Devices (B):
    Location/Room: Exhibit Hall: Solutions Circles Area (B)
    Facilitator: Matthias Fink, MD – Akra Team Inc.
    Exhibit Hall: Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)
  • Wednesday, Sep 18th
    11:45 AM – 12:15 PM PDT
    Solution Circle (B): Establishing a Regulatory Talent Pipeline Strategy for Industry 4.0
    Location/Room: Exhibit Hall: Solutions Circles Area (B)
    Facilitator: Filsun Moussa, MBA, PMP – Medtronic
    Exhibit Hall: Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)
  • Wednesday, Sep 18th
    11:45 AM – 12:15 PM PDT
    Solution Circle (D): Post-Market 510(k) and De Novo Change Management: Cinderella Strategies for Keeping Your House in Order
    Location/Room: Exhibit Hall: Solutions Circles Area (D)
    Facilitator: Kathy Herzog, BSME – DuVal & Associates, P.A.
    Exhibit Hall: Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)
  • Wednesday, Sep 18th
    12:20 PM – 12:50 PM PDT
    Solution Circle (A): LDT, RUO, IVD: What Regulatory Status for Tests Used in European Clinical Trial?
    Location/Room: Exhibit Hall: Solutions Circles Area (A)
    Facilitator: Christèle East – Namsa
    Exhibit Hall: Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)
  • Wednesday, Sep 18th
    1:00 PM – 2:00 PM PDT
    Digital Labeling and eIFU Enhance Customer Experience, Facilitate Compliance, and Improve Operational Efficiencies and Agility
    Location/Room: 102
    Presenter: Nataliya Deych – Edwards Lifesciences Sarl
    Presenter: Glenda Marsh – Johnson & Johnson Medtech
    Presenter (Remote): Elizabeth Scanlan, MSc, PhD – European Medicines Agency
    Devices (includes Medical Devices and In Vitro Diagnostics)
  • Wednesday, Sep 18th
    1:00 PM – 2:00 PM PDT
    Examining Methods to Ensure Data Quality and Privacy Considerations for AI-Enabled Medical Devices
    Location/Room: 104 C
    Session Leader: Shirley Furesz, PhD, RAC – Innomar Strategies Inc.
    Presenter: Stefan Bolleininger – be-on-Quality GmbH
    Devices (includes Medical Devices and In Vitro Diagnostics)
  • Wednesday, Sep 18th
    1:00 PM – 2:00 PM PDT
    The Importance of Data Standardization in Clinical Trials; An Update From an MDIC Supported Project
    Location/Room: 104 B
    Session Leader: John Acampado, MBA, MPH – Veeva Systems
    Presenter: Pipper White, MSc – MDIC
    Presenter: Nick Decker – Roche
    Devices (includes Medical Devices and In Vitro Diagnostics)
  • Wednesday, Sep 18th
    2:15 PM – 3:15 PM PDT
    2024 LDT Regulatory Shifts: Understanding Impacts & Strategic Adaptation for Stakeholders
    Location/Room: 101
    Presenter: Aditi Khurana, RAC, PMP, CG, MB – Summit Therapeutics
    Presenter: Cynthe Sims, PhD, HCLD(ABB) – Blackhawk Genomics
    Presenter: Monika Bhatt – Siemens Healthineers
    Devices (includes Medical Devices and In Vitro Diagnostics)
  • Wednesday, Sep 18th
    2:15 PM – 3:15 PM PDT
    Monitoring AI Devices
    Location/Room: 104 A
    Presenter: Jithesh Veetil, PhD – MDIC
    Presenter: Jay Nayar, RAC – Google
    Presenter: Tealman Bjoraker – Medtronic
    Devices (includes Medical Devices and In Vitro Diagnostics)
  • Wednesday, Sep 18th
    2:15 PM – 3:15 PM PDT
    UKCA & Market Developments
    Location/Room: 104 C
    Moderator: Sue Spencer – Qserve Group
    Presenter: Monisha Phillips, PhD – TÜV SÜD
    Presenter: Vishal Thakker, MEng – BSI
    Presenter: Robert Reid – MHRA
    Presenter: Stephen Lee – ABHI
    Devices (includes Medical Devices and In Vitro Diagnostics)
  • Wednesday, Sep 18th
    4:00 PM – 4:30 PM PDT
    Solution Circle (B): Clinical Decision Support Software vs. Software as a Medical Device
    Location/Room: Exhibit Hall: Solutions Circles Area (B)
    Facilitator: Laura Szkolar-Sienkiewicz, PhD, PMP, RAC – Microsoft
    Exhibit Hall: Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)
  • Wednesday, Sep 18th
    4:30 PM – 5:30 PM PDT
    Emerging Standard Developments in PFAS
    Location/Room: 101
    Session Leader: Catherine V. Moustakas – DEKRA Certification
    Presenter: Lindsey Zocolo – TUV SUD
    Devices (includes Medical Devices and In Vitro Diagnostics)
  • Wednesday, Sep 18th
    4:30 PM – 5:30 PM PDT
    Manufacturer's Approach to Advancing Health Equity for Medical Devices
    Location/Room: 104 A
    Presenter/Moderator: Amra Racic – Veeva Systems
    Presenter: Maria Restrepo – Medtronic
    Presenter: Lee Evans – Philips
    Devices (includes Medical Devices and In Vitro Diagnostics)
  • Wednesday, Sep 18th
    4:30 PM – 5:30 PM PDT
    What is New With Clinical Data Under the MDR? Interactive Panel Session With Notified Bodies
    Location/Room: 102
    Session Leader: Matthias Fink, MD – Akra Team Inc.
    Presenter: Richard G. Holborow – BSI
    Presenter: Christoph Ziskoven, MD – TÜV Rheinland LGA Products GmbH
    Presenter: Ulrich Nitsche, MD – TÜV SÜD Product Service GmbH
    Devices (includes Medical Devices and In Vitro Diagnostics)
  • Thursday, Sep 19th
    9:15 AM – 10:30 AM PDT
    Initial Experience with Predetermined Change Control Plans and FDA’s PCCP Guidance / Principles
    Location/Room: 104 C
    Moderator: Alex W. Smith, RAC – Hogan Lovells LLP
    Presenter: Yarmela Pavlovic – Medtronic
    Presenter: Shilpa Prem, J.D. – Amazon
    Presenter: Christopher Phillips, MSHS, RAC, CMDA – Epitel
    Presenter (Remote): Jessica Paulsen – FDA
    Devices (includes Medical Devices and In Vitro Diagnostics)
  • Thursday, Sep 19th
    9:15 AM – 10:30 AM PDT
    Notified Body Forum: State of Play EU MDR and EU IVDR
    Location/Room: 102
    Session Leader: Bassil Akra – AKRA TEAM
    Presenter: Sabina Hoekstra, PharmD FRAPS – TÜV SÜD Medical Health Services
    Presenter: Gert W. Bos, MSc, PhD and FRAPS – Qserve Group
    Presenter: Alexey Shiryaev, MD PhD – DNV Product Assurance AS
    Presenter: Suzanne Halliday, PhD – BSI
    Presenter: James Dewar – Scarlet
    Presenter: Tom Patten, MSc – GMED
    Devices (includes Medical Devices and In Vitro Diagnostics)
  • Thursday, Sep 19th
    9:15 AM – 10:30 AM PDT
    Submission Strategies for Cybersecurity: Meeting the New Bar
    Location/Room: 101
    Session Leader: Rene' Hardee – MedSec
    Presenter: Chris Reed – Medtronic
    Presenter: Edison Alvarez – BD
    Presenter: Chad Williams – Bayer
    Devices (includes Medical Devices and In Vitro Diagnostics)
  • Thursday, Sep 19th
    10:35 AM – 11:05 AM PDT
    Solution Circle (B): National Registrations and Other National Differences in the EU
    Location/Room: Exhibit Hall: Solutions Circles Area (B)
    Facilitator: Ludger J. Moeller – MDSS GmbH
    Exhibit Hall: Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)
  • Thursday, Sep 19th
    10:35 AM – 11:05 AM PDT
    Solution Circle (C): Submission of Implantable Medical Devices in Brazil: ANVISA's Class III and IV Requirements
    Location/Room: Exhibit Hall: Solutions Circles Area (C)
    Facilitator: Patricia Luchiari Verrone – Vera Rosas Group
    Exhibit Hall: Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)
  • Thursday, Sep 19th
    11:10 AM – 11:40 AM PDT
    Solution Circle (D): PCCP - Predetermined Change Control Plan - Strategy With Case Studies for Medical Devices
    Location/Room: Exhibit Hall: Solutions Circles Area (D)
    Facilitator: Abhineet Johri – Siemens Healthineers
    Exhibit Hall: Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)
  • Thursday, Sep 19th
    11:45 AM – 12:15 PM PDT
    Solution Circle (B): Emerging Standard Developments in PFAS
    Location/Room: Exhibit Hall: Solutions Circles Area (B)
    Facilitator: Catherine V. Moustakas – DEKRA Certification
    Devices (includes Medical Devices and In Vitro Diagnostics)
  • Thursday, Sep 19th
    11:45 AM – 12:15 PM PDT
    Solution Circle (C): Transformative Trends: Navigating the Evolving Regulatory Path for Laboratory Developed Tests
    Location/Room: Exhibit Hall: Solutions Circles Area (C)
    Facilitator: Ayse Demircan
    Exhibit Hall: Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)
  • Thursday, Sep 19th
    12:20 PM – 12:50 PM PDT
    Solution Circle (A): Charting the Course: Interactive Breakout Session on Navigating FDA Communication
    Location/Room: Exhibit Hall: Solutions Circles Area (A)
    Facilitator: Hilary A. Baldwin – Eximis Surgical
    Exhibit Hall: Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)
  • Thursday, Sep 19th
    1:00 PM – 2:00 PM PDT
    Best Practices for 510(k) Submissions Utilizing eSTAR
    Location/Room: 104 C
    Session Leader: Surina Gulati, MBEE – Align Technology
    Presenter: Melissa A. Hall, MS BME – Statera Regulatory Consulting
    Presenter: Prithul Bom, MS, MBA, RAC (US, EU) – Regulatory Technology Services (RTS)
    Devices (includes Medical Devices and In Vitro Diagnostics)
  • Thursday, Sep 19th
    1:00 PM – 2:00 PM PDT
    Start Ups | Unlocking Success in MedTech Innovation: Navigating Regulatory Challenges for Startups and Spin-Offs
    Location/Room: 101
    Presenter: Robert Paassen, MSc – Qserve
    Presenter: Matthias Fink, MD – Akra Team Inc.
    Presenter: Rene Pot, MSc – Indigo
    Devices (includes Medical Devices and In Vitro Diagnostics)
  • Thursday, Sep 19th
    1:00 PM – 2:00 PM PDT
    Structured Dialogue for (IVD) Medical Devices in Europe: Now Will Finally Get Some Answers
    Location/Room: 102
    Presenter: Alex Laan – BSI
    Presenter: Sabina Hoekstra, PharmD FRAPS – TÜV SÜD Medical Health Services
    Presenter: Additional Slides (Resources)
    Presenter: Volker Schluter, PhD – TüV Rheinland
    Presenter: Sue Spencer – Qserve Group
    Moderator: Francis Dekker, PhD – Thermo Fisher Scientific
    Devices (includes Medical Devices and In Vitro Diagnostics)
  • Thursday, Sep 19th
    2:30 PM – 3:00 PM PDT
    Solution Circle (A): Navigating Regulatory Pathways: When to Submit a Special 510(k) vs. Internal Letter-to-File for Device Changes (Bo
    Location/Room: Exhibit Hall: Solutions Circles Area (A)
    Facilitator: Crew J. Weunski, M.S., RAC-Devices – MediView XR, Inc.
    Exhibit Hall: Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)
  • Thursday, Sep 19th
    3:15 PM – 4:15 PM PDT
    Artificial Intelligence – Medical Devices and IVD’s conformity Assessment and CE Marking
    Location/Room: 104 B
    Session Leader: Leo Hovestadt – Elekta
    Presenter: Sarah Mathew – BSI
    Presenter: Kenneth Fuh, PhD – TÜV SÜD Product Service GmbH
    Devices (includes Medical Devices and In Vitro Diagnostics)
  • Thursday, Sep 19th
    3:15 PM – 4:15 PM PDT
    Updates From the US and EU on Furthering the Advancements of Medical Device Development in Pediatrics
    Location/Room: 104 C
    Session Leader: Amra Racic – Veeva Systems
    Presenter: Gert W. Bos, MSc, PhD and FRAPS – Qserve Group
    Presenter (Remote): Vasum Peiris, MD, MPH, FAAP, FACC, FASE – FDA
    Devices (includes Medical Devices and In Vitro Diagnostics)
  • Thursday, Sep 19th
    3:15 PM – 4:15 PM PDT
    Using Foreign Data to and From China
    Location/Room: 101
    Presenter: Grace Fu Palma, MBA – China Med Device, LLC
    Presenter/Moderator: Niedre M. Heckman, PhD, MPH, FRAPS, RAC, CQA – Takeda
    Presenter: wenkai ma – Abbvie
    Devices (includes Medical Devices and In Vitro Diagnostics)
  • Thursday, Sep 19th
    4:30 PM – 5:30 PM PDT
    A Path to Faster Breakthrough Device Commercialization - CDRH's Total Product Life Cycle Advisory Program (TAP)
    Location/Room: 201
    Session Leader: Adrienne Lenz, RAC – Hyman, Phelps & McNamara, P.C.
    Presenter: Laura Gottschalk, PhD – FDA
    Devices (includes Medical Devices and In Vitro Diagnostics)
  • Thursday, Sep 19th
    4:30 PM – 5:30 PM PDT
    Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices
    Location/Room: 101
    Session Leader: William M. Sutton – Mid-Link Group
    Devices (includes Medical Devices and In Vitro Diagnostics)