EEG caps are a proven product in the medical devices market for over 15 years. The EEG cap is a class 1 product which can be CE marked by the manufacturer if it is an ISO 13485 certified company.
The MDR requires an in-depth risk analysis and belonging documentation for proving the appropriate information for correct production and use of the product. We will describe the process and complications we experienced with the CE marking according MDR as well as technical challenges of the BrainWave Infinity EEG cap.
Peter Aben, Capable

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