scholarly journals Utilization of ICT to improve medical quality and safety related to home medical devices

2019 ◽  
Vol 89 (1) ◽  
pp. 3-11
Author(s):  
Masatoshi Watanabe ◽  
Tetsuya Misawa
Keyword(s):  
Medical Devices ◽  
Quality And Safety ◽  
Medical Quality

The Position of the German Association of Biomedical Engineering on ‘Ergonomics in Medical Technologies’

2005 ◽  
Vol 49 (11) ◽  
pp. 960-964
Author(s):  
U. Matern
Keyword(s):  
Medical Devices ◽  
Biomedical Engineering ◽  
Medical Equipment ◽  
Medical Engineering ◽  
Technical Committee ◽  
Purchase Decisions ◽  
Medical Products ◽  
Medical Quality ◽  
German Association

With an increasing employment of technology the medical quality of treatment may rise. But, at the same time, the complexity of the medical equipment rises as well. This leads to an increase of the required interactions between user and technology. Therefore, a higher work loading for the medical and nursing personal is consequential. New requirements to the safety and the quality of use of medical devices and systems result from the increasing employment of technology. For the acquisition of devices users and operators need to pay attention to the possible sources of error in handling and use as well as to the possibility to decrease operating and process costs by foresighted purchase decisions. The German Association of Biomedical Engineering (DGBMT) considered the ergonomics of medical products as an important topic and established the Technical Committee of Ergonomics in Medical Engineering. The members of this technical committee compiled a paper describing the most important issues and intentions being partly presented in the following.

scholarly journals A study on ensuring the quality and safety of pharmaceuticals and medical devices derived from processing of allogeneic human induced pluripotent stem(-Like) cells

2015 ◽  
Vol 2 ◽  
pp. 95-108 ◽  
Author(s):  
Takao Hayakawa ◽  
Takashi Aoi ◽  
Akihiro Umezawa ◽  
Keiya Ozawa ◽  
Yoji Sato ◽  
...  
Keyword(s):  
Medical Devices ◽  
Quality And Safety ◽  
Induced Pluripotent

scholarly journals A study on ensuring the quality and safety of pharmaceuticals and medical devices derived from processing of autologous human induced pluripotent stem(-like) cells

2015 ◽  
Vol 2 ◽  
pp. 81-94 ◽  
Author(s):  
Takao Hayakawa ◽  
Takashi Aoi ◽  
Akihiro Umezawa ◽  
Keiya Ozawa ◽  
Yoji Sato ◽  
...  
Keyword(s):  
Medical Devices ◽  
Quality And Safety ◽  
Induced Pluripotent

scholarly journals A Study on Immunological and Molecular Genetic Test Methods of Bacterial Sexually Transmitted Diseases Reagents

2017 ◽  
Author(s):  
Geun Soo Kim ◽  
San Kim ◽  
Hye Youn Han ◽  
Eunji Kwon
Keyword(s):  
Performance Evaluation ◽  
Sexually Transmitted Diseases ◽  
Medical Device ◽  
Medical Devices ◽  
Test Methods ◽  
Test Method ◽  
Quality And Safety ◽  
Sexually Transmitted ◽  
In Vitro Diagnosis

Chlamydia trachomatis is usally isolated only from humans and is often infected together with other sexually transmitted diseases(STD). C. trachomatis is a serious disease which infects 500 million people per year globally and causes blindness in 7 to 9 million people per year due to continuous infection. Thus, it is urgent to develop (draft) guidelines on the test methods for performance evaluation of medical devices for in vitro diagnosis of bacterial STD(C. trachomatis) based on molecular diagnosis. In this study, in reference to the U.S. FDA Guidance, has derived essential methods for testing performance which are applicable to medical device for in vitro diagnosis of bacterial STD which are used in the field of melecular diagnosis. Because of the establish of the test method for performance evaluation of medical devices, it could provide consistent performance evaluation standards for the approval and examination of products, promote the improvement of the quality and safety of products. This will contribute to the development of the quality and safety of products. This will contribute to the development of medical device for in vitro diagnosis in Korea

scholarly journals GRP-112 Medical Devices in Morocco: What Guarantees of Quality and Safety?: Abstract GRP-112 Table 1

2013 ◽  
Vol 20 (Suppl 1) ◽  
pp. A40.3-A41
Author(s):  
MA El Wartiti ◽  
W Enneffah ◽  
A Benmoussa ◽  
J Lamsaouri ◽  
S Makram ◽  
...  
Keyword(s):  
Medical Devices ◽  
Quality And Safety

scholarly journals A Study on Immunological and Molecular Genetic Test Methods of Bacterial Sexually Transmitted Diseases Reagents

2017 ◽  
Author(s):  
Geun Soo Kim ◽  
San Kim ◽  
Hye Youn Han ◽  
Eunji Kwon
Keyword(s):  
Performance Evaluation ◽  
Sexually Transmitted Diseases ◽  
Medical Device ◽  
Medical Devices ◽  
Test Methods ◽  
Test Method ◽  
Quality And Safety ◽  
Sexually Transmitted ◽  
In Vitro Diagnosis

Chlamydia trachomatis is usally isolated only from humans and is often infected together with other sexually transmitted diseases(STD). C. trachomatis is a serious disease which infects 500 million people per year globally and causes blindness in 7 to 9 million people per year due to continuous infection. Thus, it is urgent to develop (draft) guidelines on the test methods for performance evaluation of medical devices for in vitro diagnosis of bacterial STD(C. trachomatis) based on molecular diagnosis. In this study, in reference to the U.S. FDA Guidance, has derived essential methods for testing performance which are applicable to medical device for in vitro diagnosis of bacterial STD which are used in the field of melecular diagnosis. Because of the establish of the test method for performance evaluation of medical devices, it could provide consistent performance evaluation standards for the approval and examination of products, promote the improvement of the quality and safety of products. This will contribute to the development of the quality and safety of products. This will contribute to the development of medical device for in vitro diagnosis in Korea

scholarly journals A study on ensuring the quality and safety of pharmaceuticals and medical devices derived from the processing of allogeneic human somatic stem cells

2015 ◽  
Vol 2 ◽  
pp. 70-80 ◽  
Author(s):  
Takao Hayakawa ◽  
Takashi Aoi ◽  
Akihiro Umezawa ◽  
Keiya Ozawa ◽  
Yoji Sato ◽  
...  
Keyword(s):  
Stem Cells ◽  
Medical Devices ◽  
Quality And Safety ◽  
Somatic Stem Cells
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