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Regulatory processes necessary to commercialize a seizure prediction technology promises and pitfalls of biosignal analysis: seizure prediction and management (A case study);

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1 Author(s)
Poutsma, A. ; Manager Regul. Affairs, Medtronic Eur., Maastricht, Netherlands

This presentation will focus on the regulatory process followed when commercializing technology designed to predict/detect seizures. The author will describe the general requirements required to commercialize implantable medical products in the various regions of world. He will contrast the differences in the requirements for different regions and describe efforts to harmonize those requirements between the European Community and the United States. Furthermore he will identify some of the unique clinical and regulatory issues associated with commercializing a seizure management system incorporating algorithms for processing biosignals to predict/detect seizures.

Published in:

Engineering in Medicine and Biology Society, 2001. Proceedings of the 23rd Annual International Conference of the IEEE  (Volume:4 )

Date of Conference:

2001