Devices (Medical Devices & In Vitro Diagnostics) Sessions

Browse Medical Devices & In Vitro Diagnostics Sessions*.

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

Devices (Medical Devices & In Vitro Diagnostics) Sessions

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Monday, Oct 2nd
8:30 AM – 4:00 PM EDT
Common Pitfalls in Manufacturer Technical Documentation Submissions to Notified Bodies; Ways to Overcome These.
Presenter: Purvi S. Patel, PhD, CEng, MIMechE – BSI Group
Presenter: Vishal Thakker, MEng – BSI Group
Presenter: Rachel Mead, BEng MIET – BSI Group
Presenter: Alexey Shiryaev, MD PhD – DNV Product Assurance AS
Presenter: Gareth Enright, MEng – National Standards Authority of Ireland
Preconference WorkshopDevices (includes Medical Devices and In Vitro Diagnostics)
Monday, Oct 2nd
8:30 AM – 4:00 PM EDT
Communication Toolkit for a Successful Regulatory Compliance Strategy
Presenter: Corinne Delorme, MS, RAC – nexialist
Presenter: Vincent Castéras, PhD – nexialist
Presenter: Florianne Torset-Bonfillou, MS, RAC – GMED North America
Preconference WorkshopDevices (includes Medical Devices and In Vitro Diagnostics)
Tuesday, Oct 3rd
8:30 AM – 4:00 PM EDT
IVDR Technical Documentation Pre-conference Workshop
Presenter: Marta Carnielli, PharmD – TUV Sud GmbH
Presenter: Tom Patten – NSAI
Presenter: Catherine Holzmann – GMED Certification Division
Presenter: Alex Laan, Dipl.-Ing. – BSI Group The Netherlands B.V.
Preconference WorkshopDevices (includes Medical Devices and In Vitro Diagnostics)
Tuesday, Oct 3rd
8:30 AM – 4:00 PM EDT
PRRC – A New EU Requirement
Workshop Leader: Bassil Akra, phD – Akra Team GmbH
Presenter: Danielle Giroud, MSci – MD-CLINICALS SA
Presenter: Keith Morel, PhD – Qserve Group
Presenter: Alexey Shiryaev, MD PhD – DNV Product Assurance AS
Presenter: Erik R. Vollebregt – Axon Lawyers
Preconference WorkshopDevices (includes Medical Devices and In Vitro Diagnostics)
Tuesday, Oct 3rd
8:30 AM – 4:00 PM EDT
US Regulatory Essentials for Devices and IVDs
Presenter: David Chadwick, PhD, RAC, FRAPS – Independent
Presenter: Mark DuVal, J.D., FRAPS – DuVal & Associates, P.A.
Presenter: Etienne Nichols, PMP, CSM – Greenlight Guru
Presenter: Tony Blank – AtriCure, Inc.
Presenter: Christie Hughes, MPH, MLS(ASCP) – Qserve Group
Presenter (Remote): Larry Pool – Cook Incorporated
Preconference WorkshopDevices (includes Medical Devices and In Vitro Diagnostics)
Wednesday, Oct 4th
8:00 AM – 9:15 AM EDT
EU-MDR Implementation: Latest News
Moderator: Sabina Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD
Moderator: Bassil Akra, phD – Akra Team GmbH
Presenter (Remote): Peter Bischoff-Everding – European Commission, Directorate-General Health and Food safety
Presenter: Gert W. Bos, MSc, PhD, FRAPS – Qserve Group
Presenter: Suzanne Halliday, MSc. D.Phil. – BSI
Devices (includes Medical Devices and In Vitro Diagnostics)
Wednesday, Oct 4th
8:00 AM – 9:15 AM EDT
Risk Management – The Importance of Lifecycle Traceability
Session Leader: Kimberly A. Trautman, MS – MEDIcept
Presenter: Brian Siroka – MEDIcept Inc.
Devices (includes Medical Devices and In Vitro Diagnostics)
Wednesday, Oct 4th
12:05 PM – 12:35 PM EDT
Solutions Circle: Medical Device EU MDR Lessons Learned with Two Different Notified Bodies
Facilitator: Lucy Tan, MBA – Abbott
Facilitator: Jenny Chan, MS, RAC, PMP – Abbott
Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)
Wednesday, Oct 4th
12:45 PM – 1:15 PM EDT
Solutions Circle: Annex XVI State of Play
Facilitator: Alexey Shiryaev, MD PhD – DNV Product Assurance AS
Presenter: jayanth K. Katta, PhD – BSI
Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)
Wednesday, Oct 4th
12:45 PM – 1:15 PM EDT
Solutions Circle: Getting it Right the First Time - Where Regulatory and Design Intersect; Accuracy/Acceptance Criteria
Facilitator: Diane M. Ward, PhD – Qserve Group US
Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)
Wednesday, Oct 4th
2:00 PM – 3:00 PM EDT
Anatomy of a Tweet – How to Promote on the Socials in a MedDev Regulatory Environment.
Session Leader: Jennifer Ng Ain Kin – Abbott Laboratories
Presenter: Hillary VanderBand, MBA – Abbott Laboratories
Presenter: Erik R. Vollebregt – Axon Lawyers
Devices (includes Medical Devices and In Vitro Diagnostics)
Wednesday, Oct 4th
2:00 PM – 3:00 PM EDT
Transforming Patient Engagement in Medical Technologies' Evolving Regulatory Landscape
Moderator: Renee Marie Mitchell, MT (ASCP), CLS (NCA) – Boston Scientific
Presenter: Scott Goates, PhD. – Abbott
Presenter: Korinne Jew, PhD – Medtronic
Presenter: Alexandra Massoud – Exact Sciences
Presenter (Remote): Michelle Tarver, MD, PhD – U.S. Food and Drug Administration/ CDRH
Devices (includes Medical Devices and In Vitro Diagnostics)
Wednesday, Oct 4th
2:00 PM – 3:00 PM EDT
UDI & Global Supply Chain Compliance
Session Leader: Brian Scogland, MS, MBA – Veeva MedTech
Presenter: Jay Crowley, MS – USDM Life Sciences
Devices (includes Medical Devices and In Vitro Diagnostics)
Wednesday, Oct 4th
3:30 PM – 4:30 PM EDT
Advancing Health Equity, a Strategic Priority for FDA/CDRH and Health Canada
Moderator: Amra Racic – Veeva Systems
Presenter: Sally Prawdzik – Health Canada
Presenter (Remote): Michelle Tarver, MD, PhD – U.S. Food and Drug Administration/ CDRH
Devices (includes Medical Devices and In Vitro Diagnostics)
Wednesday, Oct 4th
3:30 PM – 4:30 PM EDT
EU-MDR Notified Body Forum
Moderator: Sabina Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD
Moderator: Bassil Akra, phD – Akra Team GmbH
Presenter: Suzanne Halliday, MSc. D.Phil. – BSI
Presenter: Alexey Shiryaev, MD PhD – DNV Product Assurance AS
Presenter: Andreas Stange – TUV SUD
Presenter: Catherine Holzmann – GMED Certification Division
Devices (includes Medical Devices and In Vitro Diagnostics)
Wednesday, Oct 4th
3:30 PM – 4:30 PM EDT
FDA Forecast 2024: What Device and Diagnostics Regulatory Professionals can Expect from FDA Next Year
Presenter: Alexander Gaffney, MS, RAC – POLITICO's AgencyIQ
Moderator: Amra Racic – Veeva Systems
Presenter: Laura DiAngelo, MPH – POLITICO's AgencyIQ
Devices (includes Medical Devices and In Vitro Diagnostics)
Wednesday, Oct 4th
3:30 PM – 4:30 PM EDT
Regulatory Framework of AI/ML Enabled Medical Devices in the U.S. and EU.
Presenter: Monika Bhatt, LL.M, RAC – Siemens Healthineers
Presenter: Kenneth Fuh, PhD – TÜV SÜD GmbH
Moderator: Erik R. Vollebregt – Axon Lawyers
Devices (includes Medical Devices and In Vitro Diagnostics)
Wednesday, Oct 4th
4:45 PM – 5:45 PM EDT
Efficient Product Master Data Management: FDA , EUDAMED, and other Medical Device Registry submission/Syndication.
Session Leader: Jeff Holzman – Item Alignment Inc.
Presenter: Jay Crowley, MS – USDM Life Sciences
Devices (includes Medical Devices and In Vitro Diagnostics)
Wednesday, Oct 4th
4:45 PM – 5:45 PM EDT
Latest Updates on Clinical Evidence – Panel Discussion with a Consultant and 3 Notified Bodies
Session Leader: Matthias Fink, MD – Akra Team Inc.
Presenter: Tonia Jeiter, Dr. med. – TÜV SÜD Product Service GmbH
Presenter: Richard G. Holborow – BSI
Presenter: Christoph Ziskoven, MD – TÜV Rheinland LGA Products GmbH
Devices (includes Medical Devices and In Vitro Diagnostics)
Wednesday, Oct 4th
4:45 PM – 5:45 PM EDT
When to “Factor” in Human Factors
Presenter: Rita Lin – Agilis by Kymanox
Devices (includes Medical Devices and In Vitro Diagnostics)
Thursday, Oct 5th
8:00 AM – 9:15 AM EDT
Drug-Device Combination Products: The Why Behind the Regulatory Strategy
Session Leader: Niedre M. Heckman, PhD, MPH, FRAPS, RAC, CQA – Takeda
Presenter (Remote): Theresa Jeary, BSc (Hons), MSc – BSI Group
Devices (includes Medical Devices and In Vitro Diagnostics)
Thursday, Oct 5th
8:00 AM – 9:15 AM EDT
Medical Device Cybersecurity: Planning a Global Strategy
Session Leader: Michelle Lynn Jump, MS, MSRS, ISO/TC 215 convener, RAPS instructor – MEDSEC
Presenter (Remote): Suzanne Schwartz, MD, MBA – US FDA
Devices (includes Medical Devices and In Vitro Diagnostics)
Thursday, Oct 5th
8:00 AM – 9:15 AM EDT
What can Legacy Manufacturers Learn from Effective PMS and PMPF Implementation in Order to Prepare to Become IVDR compliant?
Session Leader: Alex Laan, Dipl.-Ing. – BSI Group The Netherlands B.V.
Presenter: Susanne Klum, PhD – Dr. Ebeling & Assoc. GmbH
Presenter: Robin McMillan – Abbott
Presenter: Tom Patten – NSAI
Devices (includes Medical Devices and In Vitro Diagnostics)
Thursday, Oct 5th
10:45 AM – 11:15 AM EDT
Solutions Circle: EU/MDR State of Play
Facilitator: Sabina Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD
Facilitator: Matthias Fink, MD – Akra Team GmbH
Facilitator: Bassil Akra, phD – Akra Team GmbH
Facilitator: GERRIT WILLEM BOS, FRAPS – Qservegroup
Facilitator: Suzanne Halliday, MSc. D.Phil. – BSI
Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)Conversation Starters
Thursday, Oct 5th
12:05 PM – 12:35 PM EDT
Solutions Circle: Notified Bodies: IVDR implementation Ask me Anything
Facilitator: Azam Khorshidi – DEKRA
Facilitator: Catherine Holzmann – GMED Certification Division
Facilitator: Alex Laan, Dipl.-Ing. – BSI Group The Netherlands B.V.
Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)Conversation Starters
Thursday, Oct 5th
12:05 PM – 12:35 PM EDT
Solutions Circle: The eSTAR and I: Getting to Know the eSTAR Templates for FDA Submissions
Facilitator: Lisa L. Pritchard, BSEEE – DuVal & Associates, P.A.
Facilitator: Kathy Herzog, BSME – DuVal & Associates, P.A.
Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)Conversation Starters
Thursday, Oct 5th
12:45 PM – 1:15 PM EDT
Solutions Circle: Notified Bodies: IVDR implementation Ask me Anything
Facilitator: Anja Wiersma, PhD – mi-CE consultancy
Facilitator: Tom Patten – NSAI
Facilitator: Stefan Burde, PhD – TÜV SÜD America Inc.
Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)Conversation Starters
Thursday, Oct 5th
2:00 PM – 3:00 PM EDT
IVDR Transition and Implementation: What Have We Learned from the MDR?
Session Leader: Alex Laan, Dipl.-Ing. – BSI Group The Netherlands B.V.
Presenter: Amélie Chollet
Presenter: Erik R. Vollebregt – Axon Lawyers
Devices (includes Medical Devices and In Vitro Diagnostics)
Thursday, Oct 5th
2:00 PM – 3:00 PM EDT
Tackling a Whirlwind of Uncertainties: Lessons Learned on UK Market Access
Session Leader: Daniëlle Motta, MSc. – Qserve Group BV
Presenter: Balazs Bozsik – SGS North America Inc.
Presenter: Phil Brown – ABHI
Devices (includes Medical Devices and In Vitro Diagnostics)
Thursday, Oct 5th
2:00 PM – 3:00 PM EDT
Will EU IVDR implementation benefit from MDCG 2022-14 and if so, HOW?
Moderator: Anja Wiersma, PhD – mi-CE consultancy
Moderator: Sabina Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD
Presenter: Marta Carnielli, PharmD – TUV Sud GmbH
Presenter: Tom Patten – NSAI
Presenter: Catherine Holzmann – GMED Certification Division
Presenter: Azam Khorshidi – DEKRA
Devices (includes Medical Devices and In Vitro Diagnostics)
Thursday, Oct 5th
3:30 PM – 4:30 PM EDT
Servicing Medical Devices – What Parts or Components SIGNIFICANTLY Change the Performance or Safety (Art 23)
Moderator: Keith Morel, PhD – Qserve Group
Presenter: Leo Hovestadt – Elekta
Presenter: Balazs Bozsik – SGS North America Inc.
Devices (includes Medical Devices and In Vitro Diagnostics)
Thursday, Oct 5th
3:30 PM – 4:30 PM EDT
The eSTAR and I: Getting to Know the eSTAR Templates for FDA Submissions
Session Leader: Lisa L. Pritchard, BSEEE – DuVal & Associates, P.A.
Presenter (Remote): Patrick Axtell, PhD – FDA
Presenter: Kathy Herzog, BSME – DuVal & Associates, P.A.
Devices (includes Medical Devices and In Vitro Diagnostics)Conversation Starters
Thursday, Oct 5th
3:30 PM – 4:30 PM EDT
Understand the Evolving Role of Real World Evidence
Moderator: Olga van Grol-Lawlor, MPhil – Boston Scientific
Presenter (Remote): Daniel Caños, PhD, MPH – US Food and Drug Administration
Presenter: Heather M. Colvin, MPP – Johnson & Johnson MedTech
Speaker: Sabina L. Hoekstra -van den Bosch, PharmD FRAPS – TÜV SÜD Medical Health Services
Speaker: Monika McDole-Russell, MS, RAC – Medtronic Endoscopy
Devices (includes Medical Devices and In Vitro Diagnostics)
Thursday, Oct 5th
4:45 PM – 5:45 PM EDT
Companion Diagnostics: Overview of the IVDR Requirements and the EMA Consultation Process
Presenter: Judith Prevoo – BSI
Presenter: Iordanis Gravanis, MD, PhD – European Medicines Agency
Presenter: James Hewitt – TÜV SÜD
Presenter: Chelsea Welch – ARUP Laboratories
Moderator: Sabina Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD
Devices (includes Medical Devices and In Vitro Diagnostics)
Thursday, Oct 5th
4:45 PM – 5:45 PM EDT
Predetermined Change Control Plans (PCCPS) are Now Codified in FDORA - What should you do?
Session Leader: Nancy J. Morrison, RAC – RQM+
Presenter: Hrishikesh Gadagkar, PhD – RQM Plus
Devices (includes Medical Devices and In Vitro Diagnostics)
Thursday, Oct 5th
4:45 PM – 5:45 PM EDT
Streamlining Conformity Assessment in Medical Device Review: the FDA's ASCA Program
Moderator: Kimberly A. Trautman, MS – MEDIcept
Presenter: Gail M. Rodriguez, Ph.D. – US Food and Drug Administration
Presenter: Scott Colburn, MS, BSN – US Food and Drug Administration
Devices (includes Medical Devices and In Vitro Diagnostics)