Health Innovation Euregion 2025

12 Jun 2025 | Netherlands

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ServiceUpdated on 30 May 2025

CE marking for Medical Devices and In Vitro Diagnostic Medical Devices

Lena Bottinger

Sr. Project Manager Medical Devices at Holland Innovative

Eindhoven, Netherlands

About

The MedTech team of Holland Innovative provides expertise within:

  • Medical device development (medical devices and in vitro diagnostic medical devices) in compliance with MDR/IVDR

  • Regulatory requirements

  • Technical documentation

  • Implementation of QMS (ISO13485)

  • Risk management (ISO14971)

  • Clinical evaluation

  • Post market surveillance

We offer several ways of support for clients (short term or long term):

  • Gap analysis of existing QMS / technical documentation

  • Project management for complete or selected stages of device development

  • Clinical evaluation support

  • Internal audits and review of technical documentation

  • etc.

Organisation

Holland Innovative

Company

Eindhoven, Netherlands

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