Skip to main content
RAPS Convergence 2025 Main banner
Icon Legend
This session is not in your schedule.
This session is in your schedule. Click again to remove it.
Presentation Icons
Invitation Only
Invitation Only
Separate Ticket or Advanced Registration Required
Separate Ticket or Advanced Registration Required
Repeat Solutions Circle
Repeat Solutions Circle

  1. Home

  • Monday, Oct 6th
    8:30 AM - 4:00 PM EST
    Preconference Workshop: 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: Sean Boyd, MPH – QualityHub
    Workshop Presenter: Erik R. Vollebregt – Axon Lawyers
    Devices (includes Medical Devices & In Vitro Diagnostics)
  • Monday, Oct 6th
    8:30 AM - 4:00 PM EST
    Preconference Workshop: 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, FRAPS – 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
    Preconference Workshop: Change Management on MDR and IVDR
    Location/Room: 401
    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
    Preconference Workshop: 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, FRAPS – 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 – Hologic Inc
    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: 406
    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
    Moderator: Gert W. Bos, PhD FRAPS – QServe Group
    Moderator: Sabina L. Hoekstra-van den Bosch, PharmD, FRAPS – TÜV SÜD
    Panelist: Richard G. Holborow, n.a. – BSI
    Panelist: Matthias Bellmann, MA – TÜV SÜD Product Service GmbH
    Panelist: Bianca Lutters – QServe Consultancy B.V.
    Panelist: Leo Hovestadt – Elekta
    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
    Accelerating Regulatory Discussion on Digital Health Devices
    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
    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: 403
    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
    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, n/a – TUV Sud Product Service GmbH
    Presenter: Alex Laan – BSI BV
    Presenter: Guillaume Berger – GMED
    Presenter (Remote): Jennifer Rosendahl, PhD. – RISE
    Presenter (Remote): Aisha Sauer, PhD. – European Comission
    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, MTOPRA – 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)