International Medical Device School Experience

2021 ◽  
pp. 719-721
Author(s):  
Encey Yao
Keyword(s):  
Medical Device ◽  
School Experience ◽  
International Medical

Thrombosis of Surgical Bioprosthetic Heart Valves-Insights from Reports to International Medical Device Vigilance Systems

2017 ◽  
Vol 65 (S 01) ◽  
pp. S1-S110
Author(s):  
C. Gestrich ◽  
J.E. Klein ◽  
B. Toctam ◽  
G.D. Dürr ◽  
J.M. Sinning ◽  
...  
Keyword(s):  
Medical Device ◽  
Heart Valves ◽  
International Medical ◽  
Bioprosthetic Heart Valves

The use of standards for regulatory purposes

2019 ◽  
Vol 2019 (3) ◽  
pp. 28-30
Author(s):  
Татьяна Пика ◽  
Tat'yana Pika
Keyword(s):  
Medical Device ◽  
International Medical ◽  
Eurasian Economic Union ◽  
Economic Union

The article is dedicated to the use of standards for regulatory purposes. The analysis of the use of standards in models developed by the International Medical Device Regulators Forum (IMDRF) and Eurasian Economic Union is conducted.

International Medical Device Clinical Investigations

1999 ◽  
Author(s):  
Herman Pieterse ◽  
Marja de Jong ◽  
Peter Dujist
Keyword(s):  
Medical Device ◽  
International Medical ◽  
Clinical Investigations

scholarly journals A review of international medical device regulations: Contact lenses and lens care solutions

2019 ◽  
Vol 42 (2) ◽  
pp. 136-146 ◽  
Author(s):  
Marina Zaki ◽  
Jesús Pardo ◽  
Gonzalo Carracedo
Keyword(s):  
Medical Device ◽  
Contact Lenses ◽  
International Medical

The analysis and the review of patient registers with implanted medical devices as the tool of the post-marketing clinical monitoring of medical devices

2019 ◽  
Vol 2019 (3) ◽  
pp. 36-43
Author(s):  
Айсылу Валеева ◽  
Aysylu Valeeva ◽  
Анна Дмитриева ◽  
Anna Dmitrieva ◽  
Денис Шарикадзе ◽  
...  
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
International Medical ◽  
Clinical Monitoring ◽  
Regulatory Authorities ◽  
Implanted Medical Devices ◽  
Post Marketing

The article conducts the analysis of the practice in the application of patient registers with implanted medical devices by regulatory authorities of various countries for vigilance of medical devices, as well as review of current patient registers their categories and applicability. In addition, the article review the recommendations of The International Medical Device Regulators Forum (IMDRF) on development, implementation and application methodology of patient registers.

Global trends in circulation of medical devices

2019 ◽  
Vol 2019 (3) ◽  
pp. 21-23 ◽  
Author(s):  
Елена Астапенко ◽  
Elena Astapenko ◽  
Анна КОРТОШКИНА ◽  
Anna KORTOShKINA
Keyword(s):  
Medical Device ◽  
Russian Federation ◽  
Medical Devices ◽  
International Medical ◽  
Regulatory Environment ◽  
Global Trends ◽  
Regulatory Aspects ◽  
The Russian Federation

The article presents main tendencies in development of the legal and regulatory environment in circulation of medical devices in world’s major states. The article depicts major developed in regulatory aspects in countries members of the International Medical Device Regulators Forum (IMDRF) that took place in the late 2018 – early 2019, which are important for subjects of circulation of medical devices which planning their activities not only in the Russian Federation territory, but also abroad.

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