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 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 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

Interfacing human induced pluripotent stem cell-derived neurons with designed nanowire arrays as a future platform for medical applications

2020 ◽  
Vol 8 (9) ◽  
pp. 2434-2446 ◽  
Author(s):  
Jann Harberts ◽  
Undine Haferkamp ◽  
Stefanie Haugg ◽  
Cornelius Fendler ◽  
Dennis Lam ◽  
...  
Keyword(s):  
Stem Cell ◽  
Medical Devices ◽  
Pluripotent Stem Cell ◽  
Induced Pluripotent Stem Cell ◽  
Nanowire Arrays ◽  
Medical Applications ◽  
Next Generation ◽  
Nanostructured Substrates ◽  
Induced Pluripotent

Nanostructured substrates such as nanowire arrays form a powerful tool for building next-generation medical devices.

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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