Medical Device companies produce a wide variety of products so there is no single standard to which a specific device must be manufactured. Therefore, authorities have created a guide that all producers must follow. However, it is not easy to navigate through the maze of information. In addition, Medical Devices become more complex and testing and documentation for validation is evolving as well.
What do you need to be compliant and where do I begin?
We can help you with: Biological safety plan, Biological summary report, Gap analysis, Bridging studies, Expert statements, Testing Strategy, Risk assessments, and other?
Medical device testing and consultancy services, the full package
If you want to discuss your project with our Business Development Manager Anja Kroon or request a quotation, feel free to contact us.
If you would like more information about our Medical Device testing capabilities visit our global Medical Device website using the following link: https://www.eurofins.com/medical-device/
