Regulatory Support and Medical Devices CE Marking
We advice our customers on the regulatory requirements that apply to medical devices. Our specialists support you on both technical and regulatory aspects in order to define the most appropriate development and marketing strategies for your devices.
Marketing of Medical Devices
- Evaluation and validation of the conformity of the device
- Certification planning
- Development of the technical file
- Management of the CE marking process
- Renewal of the CE marking and update of the technical file
- Creation of specific documents: clinical evaluation report, etc.
Management of pre-clinical evaluations
We manage the relationship with the specialized laboratories and support you all along the pre-clinical evaluations:
- Test plan: definition of tests, studies and experiments to be performed
- Performing the tests: support in the process
- Creation of the pre-clinical evaluation part of the technical file
You wish to be contacted to clarify a request
Our staff will contact you as soon as possible to support you in the
definition of your request and offer you the best solution.
Why CE marking ?
The CE Mark is an indicator of the conformity of a medical device to the regulatory requirements of the European Union, particularly those relating to health and safety. It allows the free circulation of devices within the European market.