Abstract:
New regulations for medical products complicate research projects for new application fields and translation of innovative product ideas to refundable medical products be...Show MoreMetadata
Abstract:
New regulations for medical products complicate research projects for new application fields and translation of innovative product ideas to refundable medical products becomes a high economic risk. All this demands for a CE-marked platform, which offers the possibility to access the recorded data online or even directly the hardware during research applications, to bridge the gap. This paper describes how a CE-marked medical product can be extended by different interfaces to enable basic research or simplify first proof-of-concept studies thus optimizing prototype development in research projects, simplifying the documentation process and reducing the risk for market access.
Published in: 2019 41st Annual International Conference of the IEEE Engineering in Medicine and Biology Society (EMBC)
Date of Conference: 23-27 July 2019
Date Added to IEEE Xplore: 07 October 2019
ISBN Information:
ISSN Information:
PubMed ID: 31946167