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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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Devices (including Medical Devices & In Vitro Diagnostics)
Explore the Devices Track sessions at this year’s Convergence, including preconference workshops, main conference sessions, and Solutions Circles.

*Program and presenters subject to change. Please check back frequently for updates.

  • Monday, Oct 6th
    8:30 AM - 4:00 PM EST
    Expand Your Knowledge to Gain Professional Flexibility
    Location/Room: 406
    Workshop Presenter: Bassil Akra, PhD – AKRA TEAM
    Workshop Presenter: Sabina L. Hoekstra-van den Bosch, PharmD, FRAPS – TÜV SÜD
    Workshop Presenter: Gert W. Bos, PhD FRAPS – QServe Group
    Workshop Presenter: Glenda Marsh – Johnson & Johnson Medtech
    Workshop Presenter: Sean Boyd, MPH – QualityHub
    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)
    Location/Room: 315
    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
    Workshop Presenter: Deborah Sheffield
    Devices (includes Medical Devices & In Vitro Diagnostics)
  • Tuesday, Oct 7th
    8:30 AM - 4:00 PM EST
    Change Management on MDR and IVDR
    Location/Room: 403
    Workshop Leader: Anna Spehl, PhD – AKRA TEAM
    Workshop Presenter: Glenda Marsh – Johnson & Johnson Medtech
    Workshop Presenter: Poornima Bedi – Medtronic
    Workshop Presenter: Tom Patten – GMED Certification Division
    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 of 2)
    Location/Room: 315
    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
    Workshop Presenter: Deborah Sheffield
    Devices (includes Medical Devices & In Vitro Diagnostics)
  • Wednesday, Oct 8th
    9:15 AM - 10:30 AM EST
    Advertisement & Promotional Material
    Location/Room: 301
    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 – Avanos Medical, Inc.
    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
    Location/Room: 304
    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: Joao Martins – Abbott
    Presenter: Erik R. Vollebregt – Axon Lawyers
    Devices (includes Medical Devices & In Vitro Diagnostics)
  • Wednesday, Oct 8th
    11:15 AM - 11:45 AM EST
    Solutions Circle (A): Tips for Successful 10-day Conference Call with FDA
    Location/Room: Exhibit Hall: Solutions Circle A
    Facilitator: Samhitha Mohan, MS, RAC – BD - Becton, Dickinson and Company
    Repeat Solutions CircleDevices (includes Medical Devices & In Vitro Diagnostics)
  • Wednesday, Oct 8th
    11:55 AM - 12:25 PM EST
    Solutions Circle (A): Submission Gaps in Medical Devices in EU and How to Resolve
    Location/Room: Exhibit Hall: Solutions Circle A
    Facilitator: Anna Spehl, PhD – AKRA TEAM
    Repeat Solutions CircleDevices (includes Medical Devices & In Vitro Diagnostics)
  • Wednesday, Oct 8th
    11:55 AM - 12:25 PM EST
    Solutions Circle (C): State Licensing for Medical Device Companies: How Does it Apply to Me?
    Location/Room: Exhibit Hall: Solutions Circle C
    Solutions CircleDevices (includes Medical Devices & In Vitro Diagnostics)
  • Wednesday, Oct 8th
    1:00 PM - 2:00 PM EST
    A Lean System to Report Supply Interruptions and Discontinuations (Article 10a in EU, RoW)
    Location/Room: 301
    Session Leader: Lawrence Yeh, BASc – AKRA TEAM
    Presenter: Erik R. Vollebregt – Axon Lawyers
    Presenter: Anja Wiersma, PhD – mi-CE consultancy
    Presenter: Francis Dekker, PhD – Thermo Fisher Scientific
    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
    Location/Room: 403
    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 (Remote): 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
    Location/Room: 315
    Presenter: Attrayee Chakraborty, MSc., MS, CQSP – Analog Devices
    Presenter: Geethapriya K. Setty, RAC Medical Devices – Edwards LifeSciences
    Devices (includes Medical Devices & In Vitro Diagnostics)
  • Wednesday, Oct 8th
    2:15 PM - 3:15 PM EST
    Accelerating China Market Access for Medical Devices: Regulatory Shifts, Clinical Leverage & Strategic Insights
    Location/Room: 315
    Presenter: Grace F. Palma, MBA – China Med Device, LLC
    Presenter: Qianqian Zhu, MBA,LLM,RAC – Intuitive Surgical, Inc.
    Presenter: Linda He – Stryker Neurovascular International
    Presenter: Daniel Biank, JD, MEng, PE, RAC, ASQ-CMQ/OE – Accuray
    Moderator: Niedre M. Heckman, PhD, MPH, FRAPS, RAC, CQA – NOMSA Regulatory and Writing LLC
    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
    Location/Room: 406
    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
    Location/Room: 301
    Presenter: Catherine V. Moustakas – DEKRA Certification
    Presenter: Lindsey Zocolo, PMP, CSM, CLSSGB – Industry Expert
    Devices (includes Medical Devices & In Vitro Diagnostics)
  • Wednesday, Oct 8th
    3:20 PM - 3:50 PM EST
    Solutions Circle (A): Submission Gaps in Medical Devices in US and How to Resolve
    Location/Room: Exhibit Hall: Solutions Circle A
    Facilitator: Allison Komiyama, PhD, RAC, FRAPS – RQM+
    Repeat Solutions CircleDevices (includes Medical Devices & In Vitro Diagnostics)
  • Wednesday, Oct 8th
    3:20 PM - 3:50 PM EST
    Solutions Circle (C): Early Innovation: Navigating the Tech Transfer Journey from Academia to Industry
    Location/Room: Exhibit Hall: Solutions Circle C
    Facilitator: Beat U. Steffen – confinis ag
    Repeat Solutions CircleDevices (includes Medical Devices & In Vitro Diagnostics)
  • Wednesday, Oct 8th
    3:55 PM - 4:25 PM EST
    Solutions Circle (A): Navigating Novel Risks in AI/ML/LLM-Enabled Medical Devices: Regulatory and Lifecycle Risk Management Strategies
    Location/Room: Exhibit Hall: Solutions Circle A
    Facilitator: Yu Zhao, MBA, MS – Bridging Consulting LLC
    Repeat Solutions CircleDevices (includes Medical Devices & In Vitro Diagnostics)
  • Wednesday, Oct 8th
    4:30 PM - 5:30 PM EST
    AI in Medical Devices: From Regulatory Frameworks to Global Market Readiness
    Location/Room: 317
    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
    Location/Room: 315
    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
    Location/Room: 301
    Presenter: Chris Lyle, MS – DuVal & Associates, P.A.
    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
    Location/Room: 304
    Moderator: Bassil Akra, PhD – AKRA TEAM
    Presenter: Sabina L. Hoekstra-van den Bosch, PharmD, FRAPS – TÜV SÜD
    Presenter: Alexey Shiryaev, MD – DNV Product Assurance
    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
    Location/Room: 315
    Moderator: Matthias Fink – AKRA TEAM
    Presenter: Bianca Lutters – QServe Consultancy B.V.
    Presenter: Richard G. Holborow, n.a. – BSI
    Presenter: Alberto Ganan, PhD – European Medicines Agency
    Presenter: Donal O'Connor, MD FEBS – HPRA
    Devices (includes Medical Devices & In Vitro Diagnostics)
  • Thursday, Oct 9th
    9:15 AM - 10:30 AM EST
    Navigating the New US Regulatory Landscape for the MedTech Industry: Trends and Changes, Including MDUFA
    Location/Room: 301
    Moderator: Amra Racic – Veeva MedTech
    Presenter: Philip Desjardins, JD – Arnold & Porter
    Presenter: Laura DiAngelo, MPH – AgencyIQ POLITICO
    Presenter: Diana Kanecka – Medtech Europe
    Presenter: Megha Iyer, MSc, MS, RAC, FRAPS – Thermo Fisher Scientific
    Devices (includes Medical Devices & In Vitro Diagnostics)
  • Thursday, Oct 9th
    10:35 AM - 11:05 AM EST
    Solutions Circle (B): Quality Culture: How to Make Meaningful Impact as an Early-Career Professional
    Location/Room: Exhibit Hall: Solutions Circle B
    Facilitator: Attrayee Chakraborty, MSc., MS, CQSP – Analog Devices
    Solutions CircleDevices (includes Medical Devices & In Vitro Diagnostics)
  • Thursday, Oct 9th
    11:15 AM - 11:45 AM EST
    Solutions Circle (A): Tips for successful 10-day Conference Call with FDA
    Location/Room: Exhibit Hall: Solutions Circle A
    Facilitator: Samhitha Mohan, MS, RAC – BD - Becton, Dickinson and Company
    Repeat Solutions CircleDevices (includes Medical Devices & In Vitro Diagnostics)
  • Thursday, Oct 9th
    11:55 AM - 12:25 PM EST
    Solutions Circle (A): Submission Gaps in Medical Devices in EU and How to Resolve
    Location/Room: Exhibit Hall: Solutions Circle A
    Facilitator: Anna Spehl, PhD – AKRA TEAM
    Repeat Solutions CircleDevices (includes Medical Devices & In Vitro Diagnostics)
  • Thursday, Oct 9th
    1:00 PM - 2:00 PM EST
    A Case Study on Health Equity Through the Lens of Pulse Oximetry
    Location/Room: 301
    Presenter: Shannon Ryan, MEng, RAC – Medtronic
    Moderator: Amra Racic – Veeva MedTech
    Devices (includes Medical Devices & In Vitro Diagnostics)
  • Thursday, Oct 9th
    1:00 PM - 2:00 PM EST
    Accelerating Postmarket Innovation with Predetermined Change Control Plans (PCCPs): AI/ML and Beyond
    Location/Room: 315
    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
    Location/Room: 406
    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
    Solutions Circle (A): Submission Gaps in Medical Devices in US and How to Resolve
    Location/Room: Exhibit Hall: Solutions Circle A
    Facilitator: Allison Komiyama, PhD, RAC, FRAPS – RQM+
    Repeat Solutions CircleDevices (includes Medical Devices & In Vitro Diagnostics)
  • Thursday, Oct 9th
    2:05 PM - 2:35 PM EST
    Solutions Circle (C): Early Innovation: Navigating the Tech Transfer Journey from Academia to Industry
    Location/Room: Exhibit Hall: Solutions Circle C
    Facilitator: Beat U. Steffen – confinis ag
    Repeat Solutions CircleDevices (includes Medical Devices & In Vitro Diagnostics)
  • Thursday, Oct 9th
    2:40 PM - 3:10 PM EST
    Solutions Circle (A): Navigating Novel Risks in AI/ML/LLM-Enabled Medical Devices: Regulatory and Lifecycle Risk Management Strategies
    Location/Room: Exhibit Hall: Solutions Circle A
    Facilitator: Yu Zhao, MBA, MS – Bridging Consulting LLC
    Repeat Solutions CircleDevices (includes Medical Devices & In Vitro Diagnostics)
  • Thursday, Oct 9th
    3:15 PM - 4:15 PM EST
    Cybersecurity Regulations and Policy: FDA and Beyond
    Location/Room: 315
    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
    Location/Room: 304
    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
    US & EU Perspectives on AI Regulation
    Location/Room: 317
    Session Leader: Suchitra (Suchi) Basu, PhD – J&J MedTech
    Presenter: Alex Cadotte, PhD – MCRA, an IQVIA Company
    Presenter: Anupama Govindarajan, PhD – Johnson & Johnson MedTech | Heart Recovery
    Presenter: Ajit Sankar Mallik – Accenture
    Presenter (Remote): MiRa Jacobs – U.S. Food and Drug Administration (FDA)
    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
    Location/Room: 304
    Presenter: Marta Carnielli – TÜV SÜD
    Presenter: Alex Laan – BSI BV
    Presenter: Guillaume Berger – GMED
    Presenter (Remote): Jennifer Rosendahl, PhD. – RISE
    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
    Location/Room: 315
    Devices (includes Medical Devices & In Vitro Diagnostics)
  • Thursday, Oct 9th
    4:30 PM - 5:30 PM EST
    Scaling the Pond: Routes to Market in the UK and Switzerland
    Location/Room: 406
    Moderator: Megha Iyer, MSc, MS, RAC, FRAPS – Thermo Fisher Scientific
    Presenter: Ashleigh Batchen – TÜV SÜD
    Presenter: Vishal Thakker, MEng – BSI
    Presenter: Elaine Grimes – Medicines and Healthcare products Regulatory Agency (MHRA)
    Presenter: Bernhard Bichsel – ISS AG, Integrated Scientific Services
    Devices (includes Medical Devices & In Vitro Diagnostics)