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MedTech Summit

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16 - 20 June 2025
Mercure Hotel MOA Berlin, Berlin, GermanyHybrid Event I Attend In-Person or Digitally
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Day One – 16 June 2025 - CEST Time Zone

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Day One – 16 June 2025 - CEST Time Zone
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Showing 1 of 1 Streams
08:40 - 08:50
Chairperson’s Opening Remarks: SME Survival Guide
  • Arjun Amin - Chief Operating Officer, EyeSpace
  • Tom Patten - IVDR/IVD International Manager, GMED
  • Tatsiana Ripich - Head of Regulatory Affairs, enmodes GmbH
  • Robert Paassen - Consultant, Qserve
  • Elem Ayne - President, TEAM-PRRC
  • Sascha Wettmarshausen - Deputy Managing Director, Verband der Diagnostica-Industrie e.V (VDGH)
08:50 - 09:35
Market Analysis
  • EU vs US
    • Identifying target markets and customer segments
    • Assessing market potential and competitive landscape
  • How to curate a regulatory and clinical strategy from the ground up
  • Robert Paassen - Consultant, Qserve
  • Tatsiana Ripich - Head of Regulatory Affairs, enmodes GmbH
  • Arjun Amin - Chief Operating Officer, EyeSpace
09:35 - 10:10
Introduction to the Medical Devices Regulation (MDR) and In Vitro Diagnostic Devices Regulation (IVDR)
  • Key changes and implications for SMEs
  • Understanding the regulatory classification system
  • Robert Paassen - Consultant, Qserve
  • Tom Patten - IVDR/IVD International Manager, GMED
  • Sascha Wettmarshausen - Deputy Managing Director, Verband der Diagnostica-Industrie e.V (VDGH)
Showing 1 of 1 Streams
11:10 - 11:55
Supplier Selection and Engagement
  • Criteria for choosing a notified body, consultant, and Person Responsible for Regulatory Compliance (PRRC)
  • The role of each supplier in the regulatory process
  • Elem Ayne - President, TEAM-PRRC
  • Tom Patten - IVDR/IVD International Manager, GMED
  • Robert Paassen - Consultant, Qserve
  • Tatsiana Ripich - Head of Regulatory Affairs, enmodes GmbH
  • Arjun Amin - Chief Operating Officer, EyeSpace
11:55 - 12:40
Phases of QMS
  • Why do i need a QMS?
    • EU vs US
  • How to build an efficient and sustainable QMS
  • Best practices for keeping it lean
  • Tatsiana Ripich - Head of Regulatory Affairs, enmodes GmbH
  • Elem Ayne - President, TEAM-PRRC
  • Arjun Amin - Chief Operating Officer, EyeSpace
  • Robert Paassen - Consultant, Qserve
  • Tom Patten - IVDR/IVD International Manager, GMED
Showing 1 of 1 Streams
14:10 - 14:15
Chairperson’s Afternoon Remarks: SME Survival Guide
  • Arjun Amin - Chief Operating Officer, EyeSpace
  • Tom Patten - IVDR/IVD International Manager, GMED
  • Tatsiana Ripich - Head of Regulatory Affairs, enmodes GmbH
  • Robert Paassen - Consultant, Qserve
  • Elem Ayne - President, TEAM-PRRC
14:15 - 15:45
Technical File and Strategy Preparation
  • Essential components of the technical file
  • Best practices for documentation and evidence generation
  • Tom Patten - IVDR/IVD International Manager, GMED
  • Tatsiana Ripich - Head of Regulatory Affairs, enmodes GmbH
  • Robert Paassen - Consultant, Qserve
  • Sascha Wettmarshausen - Deputy Managing Director, Verband der Diagnostica-Industrie e.V (VDGH)
Showing 1 of 1 Streams
16:15 - 17:00
Curating Funding, Pricing and Reimbursement Strategies
  • Funding
    • Overview of funding options (e.g., grants, loans, venture capital, private equity)
    • Creating a compelling investment pitch
  • Pricing
    • Methods to evaluate and determine pricing
  • Reimbursement
    • Understanding reimbursement pathways in different European countries
  • Arjun Amin - Chief Operating Officer, EyeSpace
17:00 - 17:45
Ask Us Anything!
  • Arjun Amin - Chief Operating Officer, EyeSpace
  • Tom Patten - IVDR/IVD International Manager, GMED
  • Tatsiana Ripich - Head of Regulatory Affairs, enmodes GmbH
  • Elem Ayne - President, TEAM-PRRC
  • Sascha Wettmarshausen - Deputy Managing Director, Verband der Diagnostica-Industrie e.V (VDGH)
  • Robert Paassen - Consultant, Qserve
NextDay Two – 17 June 2025
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