Endo Engineering provides a comprehensive and competent consulting service together with all the necessary services for the CE marking of medical devices and for the certification to export to the Non-European countries.
The company uses the items of the Directive, applicable technical standards and prepares all the documentation necessary for submission of the certification application.
The services for medical devices certification are:
- Risk analysis of the product
- Performing testing and laboratory tests
- Analysis of safety systems
- Compliance checks and compliance with technical standards
- Technical assistance project for the development of safe product
- Realization of technical documentation
- Clinical Trial