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MedTech Summit
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
08:30 - 08:40
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
08:40 - 09:25
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

09:25 - 10:40
Notified Body Selection and Engagement

  • Criteria for choosing a notified body

  • The role of the notified body in the regulatory process

Showing 1 of 1 Streams
11:10 - 12:40
Technical File and Strategy Preparation

  • Essential components of the technical file

  • Best practices for documentation and evidence generation

  • How to curate a regulatory and clinical strategy from the ground up

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 - 15:00
European Market Analysis

  • Identifying target markets and customer segments

  • Assessing market potential and competitive landscape

15:00 - 15:45
Reimbursement and Pricing Strategies

  • Understanding reimbursement pathways in different European countries

  • Developing effective pricing strategies

Showing 1 of 1 Streams
16:15 - 17:00
Securing Funding for Medical Device Development and Commercialization

  • Overview of funding options (e.g., grants, loans, venture capital, private equity)

  • Developing a compelling investment pitch

  • Navigating the fundraising process

17:00 - 17:45
Ask Us Anything!
NextDay Two – 17 June 2025
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