Research platform for medical device development to simplify translation to the market
Journal
Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference
ISSN: 2694-0604
Titre abrégé: Annu Int Conf IEEE Eng Med Biol Soc
Pays: United States
ID NLM: 101763872
Informations de publication
Date de publication:
Jul 2019
Jul 2019
Historique:
entrez:
18
1
2020
pubmed:
18
1
2020
medline:
13
3
2020
Statut:
ppublish
Résumé
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.
Identifiants
pubmed: 31946167
doi: 10.1109/EMBC.2019.8857935
doi:
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM