Revision history of "Subcutaneous neurologic electrodes certification by CE marking according to Council Directive 93/42/EEC concerning medical devices" (Q2729958)

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10 October 2024

  • curprev 08:1408:14, 10 October 2024DG Regio talk contribs 57,078 bytes −1 Changed label, description and/or aliases in pt
  • curprev 08:1408:14, 10 October 2024DG Regio talk contribs 57,079 bytes +17 Set a claim value: summary (P836): O projeto tem por objeto uma aquisição com a marcação CE de três dispositivos médicos, um elétrodo da OIM que monitoriza o estado dos seus sistemas nervoso e muscular. O processo de certificação deve consistir numa série de ensaios e estudos de compatibilidade, nomeadamente a preparação da documentação técnica antes do próprio certificado. Em consonância com os numerosos novos requisitos decorrentes da Diretiva 93/42/CEE do Conselho, a empresa tem d...

12 August 2024

7 March 2024

19 June 2023

11 June 2023

1 June 2023

12 October 2022

11 July 2022

  • curprev 01:4301:43, 11 July 2022DG Regio talk contribs 56,909 bytes +34,262 Changed label, description and/or aliases in da, el, ro, sk, mt, pt, fi, pl, sl, cs, lt, lv, bg, hu, ga, sv, et, hr, nl, fr, de, it, es, and other parts: Adding translations: da, el, ro, sk, mt, pt, fi, pl, sl, cs, lt, lv, bg, hu, ga, sv, et,

13 January 2022

11 January 2022

4 December 2021

29 November 2021

  • curprev 19:0819:08, 29 November 2021DG Regio talk contribs 16,858 bytes +1,739 Created claim: summary (P836): Gegenstand des Projekts ist die Einführung von CE ZNAK für 3 Gruppen von Medizinprodukten, IOM-Elektroden, die den Zustand des Nerven- und Muskelsystems des Patienten überwachen. Das Zertifizierungsverfahren besteht aus einer Reihe von Tests und Kompatibilitätsstudien, d. h. der Vorbereitung der technischen Dokumentation, die dem Erhalt des Zertifikats vorausgeht. Entsprechend den zahlreichen neuen Anforderungen, die sich aus der RICHTLINIE 93/...
  • curprev 19:0819:08, 29 November 2021DG Regio talk contribs 15,119 bytes +175 Changed label, description and/or aliases in de: translated_label
  • curprev 09:4709:47, 29 November 2021DG Regio talk contribs 14,944 bytes +1,800 Created claim: summary (P836): L’objet du projet est l’introduction de CE ZNAK pour 3 groupes de dispositifs médicaux, les électrodes de l’OIM, qui surveillent l’état du système nerveux et musculaire du patient. Le processus de certification consiste en une série d’essais et d’études de compatibilité, c’est-à-dire la préparation de la documentation technique qui précède l’obtention même du certificat. Conformément aux nombreuses nouvelles exigences découlant de la DIRECTIVE...

26 November 2021

21 June 2021

3 June 2021

  • curprev 10:1810:18, 3 June 2021DG Regio talk contribs 12,513 bytes +190 Changed label, description and/or aliases in en: translated_label
  • curprev 10:1810:18, 3 June 2021DG Regio talk contribs 12,323 bytes +1,589 Created claim: summary (P836): The project’s subject matter is a CE marked acquisition of 3 medical devices, IOM electrode monitoring the state of its nervous and muscle systems. The certification process shall consist of a series of tests and compatibility studies, namely the preparation of technical documentation prior to the certificate itself. In line with the numerous new requirements arising from Council Directive 93/42/EEC, the company has to change the composition an...

2 June 2021