DocumentCode :
708992
Title :
Streamlining medical device design development process from research laboratory to the market
Author :
Koivukangas, Tapani ; Lukkari, Junnu ; Haapola, Jussi ; Kohno, Ryuji
Author_Institution :
Lewel Group Finland Oy, Oulu, Finland
fYear :
2015
fDate :
24-26 March 2015
Firstpage :
98
Lastpage :
102
Abstract :
The objective of this paper is to describe the common conformity assessment procedures to comply with the regulations in certifying devices for medical use. This paper also defines the main aspects of medical devices in general with common key differences between medical devices and consumer products. Furthermore, this paper highlights the role and importance of literature research in medical device development, particularly in shortening the time-to-market and in the certification process. Finally, this paper gives the researchers of institutes and universities suggestions on what could be taken into account at the very early phase of ideation of possible methods and products that are intended to be classified as a medical device.
Keywords :
biomedical equipment; marketing; product design; standards; time to market; common conformity assessment procedure; consumer product; early ideation phase; institute research suggestion; literature research; medical device certification; medical device classification; medical device design development streamlining; medical use; regulation compliance; research laboratory; time-to-market shortening; university research suggestion; Consumer products; Industries; Medical diagnostic imaging; Medical services; Product development; Standards; International standards; Medical device classification; Medical device regulations; Product development;
fLanguage :
English
Publisher :
ieee
Conference_Titel :
Medical Information and Communication Technology (ISMICT), 2015 9th International Symposium on
Conference_Location :
Kamakura
Type :
conf
DOI :
10.1109/ISMICT.2015.7107506
Filename :
7107506
Link To Document :
بازگشت