Zobrazeno 1 - 10
of 276
pro vyhledávání: '"CE marking"'
Publikováno v:
AboutOpen, Vol 11, Iss 1 (2024)
The market placing of a medical device in compliance with the requirements of EU Regulation 2017/745 (Medical Device Regulation) demands advanced regulatory expertise and a high level of detail and depth, inevitably leading to significant human and t
Externí odkaz:
https://doaj.org/article/58cbe245a29f4f42af76edf5c1b798e3
Publikováno v:
International Journal for Quality Research, Vol 18, Iss 1, Pp 153-166 (2024)
This work aims to highlight the factors that characterize quality systems in the case of pressure equipment manufacturing. For the CE marking, according to the Pressure Equipment Directive (PED), the manufacturer may adopt conformity assessment modul
Externí odkaz:
https://doaj.org/article/5471df4361f64dc69c78e16e6840922e
Publikováno v:
Orphanet Journal of Rare Diseases, Vol 18, Iss 1, Pp 1-13 (2023)
Abstract Aim To determine the level of evidence for innovative high-risk medical devices at market entry. Methods We reviewed all Belgian healthcare payer (RIZIV-INAMI) assessor reports on novel implants or invasive medical devices (n = 18, Class IIb
Externí odkaz:
https://doaj.org/article/604e469d17d24aad963354bd229ab9d6
Akademický článek
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Autor:
Majkowska-Szulc, Sylwia
Publikováno v:
Gdańskie Studia Prawnicze / Gdańsk Legal Studies. I(49):133-145
Externí odkaz:
https://www.ceeol.com/search/article-detail?id=984812
Publikováno v:
Paladyn, Vol 11, Iss 1, Pp 414-427 (2020)
Wearable robots are devices intended to improve the quality of users’ life by augmenting, assisting, or substituting human functions. Exoskeletons are one of the most widespread types of wearable robots, currently used extensively in medical applic
Externí odkaz:
https://doaj.org/article/8209d4052ab04adfbe70f8b305215215
Autor:
Michelin, Linus, Cantillana, Emilia
I detta arbete undersöks lämpliga materialval och tillverkningsmetoder för medicintekniska produkter, specifikt för SwiftVitals - en sensorenhet utvecklad för att mäta livsviktiga kroppsfunktioner som EKG och syremättnad i blodet. De vanligast
Externí odkaz:
http://urn.kb.se/resolve?urn=urn:nbn:se:kth:diva-349215
Publikováno v:
Proceedings on Engineering Sciences, Vol 1, Iss 2, Pp 563-568 (2019)
Development countries should create an environment for the successful integration of their economy into the European and international processes, and it is only possible with the harmonization of national legislation with the EU, and acceptance of Eu
Externí odkaz:
https://doaj.org/article/e7a1888cc19e46918ba1ecb0859d5906
Autor:
Isabel Santamaría Vicario, Verónica Calderón Carpintero, Sara Gutierrez González, Ángel Rodríguez Saiz
Publikováno v:
Building & Management, Vol 3, Iss 2, Pp 6-15 (2019)
The process of preparing a “Declaration of Performance” is presented for a masonry mortar manufactured with by-products from the steelmaking industry recycled as aggregates, for subsequent CE Marking, with the aim of promoting its commercializati
Externí odkaz:
https://doaj.org/article/e8d556dd1eea40a0a906f7e003ac61e8
Akademický článek
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