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Preconference Workshops

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Preconference Workshops

All Preconference workshops require a separate registration fee and are not included in main conference pricing. Learn more:  https://www.raps.org/europe-2023/register

Preconference Workshops

  • Thursday, May 11th
    09:00 – 10:00 CEST
    Data Security & Digital Health: Medical Devices, IVDs and the Increasing EU Regulation of Health Data
    Location: Pearl 3
    Moderator & Presenter: Erik R. Vollebregt – Axon Lawyers
    Presenter: Cécile E. Van der Heijden, LLM – Axon Lawyers
    Presenter: Agnes Szoboszlai – Philips Medical Systems Nederland B.V.
    Presenter: Leo Hovestadt – Elekta
    Medical DevicesDomain: EthicsKnowledge Area: Legal & Regulatory Requirements
    Supported by 
  • Thursday, May 11th
    09:00 – 10:00 CEST
    MDCG 2022-14: Game-Changer or 'Shopping List' for MDR Implementation?
    Location: Pearl 2
    Moderator: Sabina L. Hoekstra -van den Bosch, PharmD FRAPS – TÜV SÜD Medical Health Services
    Moderator: Gert W. Bos, FRAPS, MSc, PhD, FRAPS – Qserve Group
    Presenter: Flora Giorgio – European Commission
    Presenter: Royth Philippp von Hahn, PhD – TUV SUD Product Services
    Presenter: Graeme Turnbridge – BSI
    Presenter: Alexandre Jauniaux – Federal Agency of Medicines and Health products
    Medical DevicesDomain: Product Development & RegistrationKnowledge Area: Regulatory Guidance
    Supported by 
  • Thursday, May 11th
    10:30 – 11:30 CEST
    Clinical Evaluation: Measurable Outcome Parameters: Much More Than a Requirement for an MDR-Complaint CER
    Location: Pearl 2
    Moderator: Gert W. Bos, FRAPS, MSc, PhD, FRAPS – Qserve Group
    Presenter: María Cámara Torres, PhD – Qserve Group
    Presenter: Lise Op de Beeck – GymnaUniphy
    Presenter: Jorn van Binsbergen, MSc – Qserve Group
    Medical DevicesDomain: Scientific & Health ConceptsKnowledge Area: Application of Scientific & Clinical Advances
    Supported By
  • Thursday, May 11th
    10:30 – 11:30 CEST
    Traceability of devices; the administrative burden or a smart set-up for legal manufacturers?
    Location: Pearl 3
    Moderator: Susana de Azevedo Wäsch – Ypsomed
    Presenter: Daniëlle Motta, MSc. – Qserve Group
    Presenter: Lionel Tussau – atrify
    Medical DevicesDomain: Product Development & RegistrationKnowledge Area: Documentation
    Supported By
  • Thursday, May 11th
    11:45 – 12:45 CEST
    Clinical assessment: how to minimize the questions from your Notified Body
    Location: Pearl 2
    Moderator: Giovanni Di Rienzo – Qserve Group
    Presenter: Sheila Walsh – BSI
    Presenter: Alexey Shiryaev, MD PhD – DNV Product Assurance AS
    Medical DevicesDomain: Product Development & RegistrationKnowledge Area: Documentation
    Supported By
  • Thursday, May 11th
    11:45 – 12:45 CEST
    Using TPLC and GMLP as Your Lighthouse, When Sailing Blind Among AI Icebergs
    Location: Pearl 1
    Moderator & Presenter: Catarina Carrão – BioSciPons
    Moderator & Presenter: Koen Cobbaert – Philips
    Medical DevicesDomain: Regulatory Frameworks & StrategyKnowledge Area: Process & Procedures
    Supported By
  • Thursday, May 11th
    13:45 – 14:45 CEST
    AI/machine learning based-medical software: case studies on model development and regulatory compliance
    Location: Pearl 1
    Moderator: Leo Louis, RAC, PMP – Philips
    Presenter: abhineet johri, MCA – Siemens Healthineers
    Presenter: Martina Coscia, PhD – confinis AG
    Presenter: Beat Steffen, MSc, FRAPS – confinis ag
    Medical DevicesDomain: Product Development & RegistrationKnowledge Area: Market Strategy
    Supported By
  • Thursday, May 11th
    15:00 – 16:00 CEST
    Medical Device Regulation in International Perspective: EU IMDRF Chair in 2023
    Location: Pearl 3
    Moderator: Sabina L. Hoekstra -van den Bosch, PharmD FRAPS – TÜV SÜD Medical Health Services
    Presenter: Gert W. Bos, FRAPS, MSc, PhD, FRAPS – Qserve Group
    Presenter: Flora Giorgio – European Commission
    Presenter: Sietske Eerens – Dutch Health and Youth Care Inspectorate
    Medical DevicesDomain: Business AcumenKnowledge Area: Industry-specific Knowledge
    Supported By
  • Thursday, May 11th
    15:00 – 16:00 CEST
    Responsibilities and Liabilities in an Interconnected World
    Location: Pearl 2
    Moderator: Susana de Azevedo Wäsch – Ypsomed
    Presenter: Koen Cobbaert – Philips
    Presenter: Erik R. Vollebregt – Axon Lawyers
    Presenter: Celia Cruz, PhD – Complear
    Medical Devices
    Supported By
  • Thursday, May 11th
    16:45 – 17:45 CEST
    Expert Advisory Panel - What Have we Learned?
    Location: Pearl 1
    Presenter: Richard Holborow – BSI
    Presenter: Silvy Da Rocha Dias – European Medicines Agency
    Presenter: Rohan Shah, BS – BD
    Medical DevicesDomain: Product Development & RegistrationKnowledge Area: General
    Supported By
  • Thursday, May 11th
    16:45 – 17:45 CEST
    Regulation Changes: Incentives for Pediatric Medical Devices in the US and Japan. Implications for the EU.
    Location: Pearl 3
    Presenter: Stephanie Huebner, MSc, PhD – Olympus Surgical Technologies Europe
    Medical DevicesDomain: Regulatory Frameworks & StrategyKnowledge Area: Market Strategy
    Supported By
  • Friday, May 12th
    10:45 – 11:45 CEST
    Device Lifetime and Lifecycle Management
    Location: Pearl 3
    Moderator: Giovanni Di Rienzo – Qserve Group
    Presenter: Richard A. Vincins, RAC-MD, CMDA, CQA – Oriel STAT A MATRIX
    Presenter: Matthias Bellmann, MA – TÜV SÜD Product Service GmbH
    Medical DevicesDomain: Post Approval/Post MarketKnowledge Area: Recordkeeping, Monitoring
    Supported By
  • Friday, May 12th
    10:45 – 11:45 CEST
    Medical Device Software: Top Recurrent Regulatory Deficiencies from Both FDA and Notified Bodies
    Location: Pearl 1
    Moderator: Amie Smirthwaite, BEng, PhD – RQM+
    Presenter: Nancy J. Morrison, RAC – RQM+
    Presenter: Abtin Rad, Dr. – TÜV SÜD Product Services
    Medical DevicesDomain: Product Development & RegistrationKnowledge Area: Regulatory Guidance
    Supported By
  • Friday, May 12th
    12:00 – 13:00 CEST
    Real World Evidence...What Could Possibly go Wrong? A Clinician's Perspective
    Location: Pearl 2
    Moderator: Gert W. Bos, FRAPS, MSc, PhD, FRAPS – Qserve Group
    Presenter: Sophie Tabutin, PharmD, MSc – W.L. Gore & Associates
    Presenter: Gavin Quigley, MBChB FRCS MBA – BSI
    Presenter: Joshua Bridgens, MBBS FRCS – DePuy Synthes (J&J)
    Medical DevicesDomain: Regulatory Frameworks & StrategyKnowledge Area: Data Management & Analysis
    Supported By
  • Friday, May 12th
    12:00 – 13:00 CEST
    UKCA: challenges and opportunities
    Location: Pearl 3
    Moderator: Giovanni Di Rienzo – Qserve Group
    Presenter: Phil Brown
    Presenter: Vishal Thakker, MEng – BSI Group
    Presenter: Jillan Hussein, MEng – MHRA
    Medical Devices
    Supported By
  • Friday, May 12th
    14:00 – 15:00 CEST
    Standards & Compliance: Updates on ‘Sustainable’ Medical Devices
    Location: Pearl 2
    Moderator: Leo Louis, RAC, PMP – Philips
    Presenter: Keti S. Agostino, n/a – BSI
    Presenter: Michelle Sullivan – Boston Scientific
    Medical DevicesDomain: Scientific & Health ConceptsKnowledge Area: Healthcare Leadership
    Supported By
  • Friday, May 12th
    15:30 – 16:30 CEST
    Closing Panel: Impact of MDCG 2022-14 Position Paper on NB Capacity Since Publication
    Location: Pearl 1
    Moderator: Robert A. van Boxtel – Medical Device Project B.V.
    Presenter: Kevin Madden – BSI Group
    Presenter: Martin Witte – TÜV SÜD Product Service GmbH
    Presenter: Paul Kosters, PhD – DEKRA Certification BV
    Medical DevicesDomain: Regulatory Frameworks & StrategyKnowledge Area: Data Management & Analysis
    Supported By
  • Friday, May 12th
    15:30 – 16:30 CEST
    Cybersecurity: Compliantly Securing our Healthcare Future
    Location: Pearl 3
    Moderator & Presenter: Michelle Jump, RAC – MedSec LLC
    Medical DevicesDomain: Product Development & RegistrationKnowledge Area: Market Strategy
    Supported By