ExpertiseUpdated on 30 May 2025
(In vitro diagnostic) medical devices: regulatory expertise
About
The MedTech team of Holland Innovative provides expertise within:
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Medical device development (medical devices and in vitro diagnostic medical devices) in compliance with MDR/IVDR
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Regulatory requirements
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Technical documentation
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Implementation of QMS (ISO13485)
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Risk management (ISO14971)
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Clinical evaluation
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Post market surveillance
We offer several ways of support for clients (short term or long term):
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Gap analysis of existing QMS / technical documentation
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Project management for complete or selected stages of device development
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Clinical evaluation support
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Internal audits and review of technical documentation
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etc.
Organisation
Similar opportunities
Service
CE marking for Medical Devices and In Vitro Diagnostic Medical Devices
Lena Bottinger
Sr. Project Manager Medical Devices at Holland Innovative
Eindhoven, Netherlands
Expertise
Lena Bottinger
Sr. Project Manager Medical Devices at Holland Innovative
Eindhoven, Netherlands
Service
Quality and regulatory (QA/RA) consultancy for medical device sector
- Other
- Consulting
- Life Science
- Education, Training & Qualifying
Jeannette van Loon
CEO at Medical Device Project B.V.
Alphen aan den Rijn, Netherlands