Health Innovation Euregion 2025

12 Jun 2025 | Netherlands

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ExpertiseUpdated on 30 May 2025

(In vitro diagnostic) medical devices: regulatory expertise

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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