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
Why choose Eurofins Medical Device Services?
- Single point of contact. Benefit from streamlined communication through a single local point of contact while leveraging the advantages of our extensive global network.
- Complete service portfolio. Leveraging our network of regulatory experts, laboratories, and sterile packaging sites in Europe, North America, & Asia Pacific, we can offer a comprehensive service portfolio to our customers.
- Extensive expertise. Companies of all sizes benefit from our 40+ years of expertise and capabilities to ready their products for market launch and post-marketing activities through three independent services: consulting, testing, and sterile packaging.
If you would like to discuss your project and needs 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, please also visit our global Medical Device website using the following link: https://www.eurofins.com/medical-device/
