ExpertiseUpdated on 30 May 2025
(In vitro diagnostic) medical devices: regulatory expertise
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
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