ISS AG
Robert-Walser-Platz 7
CH-2503 Biel
Switzerland
Tel. +41 32 513 67 67
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ARIAQ et ISS AG proposent une formation d’une demi-journée pour les fabricants de dispositifs médicaux dont l’objectif est d’illustrer les exigences des évaluations cliniques selon « MEDDEV 2.7/1, Révision 4 » par des exemples concrets de mise en application en Suisse.

Actuellement, la création d’une évaluation clinique est un défi pour l’industrie. Cette formation offre un programme ad hoc vous permettant d’acquérir les connaissances fondamentales pour relever ce défi.

Description générale

Conformément aux attentes, la dernière révision du document concernant la phase d’évaluation clinique des DM publiée par la Commission Européenne est plus complète. Plus précisément, le document présente de manière plus détaillée un certain nombre de cas afin de clarifier des exigences préexistantes. L’accent est particulièrement mis sur le travail à effectuer par les fabricants pour l’organisation de tests cliniques fiables. Il s’agit donc de démontrer la validité scientifique des conclusions basées sur un traitement irréprochable des données.

ARIAQ et ISS proposent une formation dont le but est d’illustrer par des exemples pratiques comment les fabricants de DM peuvent répondre aux exigences du MEDDEV Rév 4.

Le programme
  • Importance des données cliniques pour les fabricants de dispositifs médicaux
  • Les exigences réglementaires en Europe
  • MEDDEV 2.7/1 - Lignes directrices pour les fabricants et les organismes notifiés
  • MEDDEV 2.7/1 Révision 4 - Quels sont les changements principaux?
  • L'évaluation clinique après MEDDEV 2.7/1 Révision 4 (Partie 1)
  • Définition du scope: Planification, Questions, Équivalence
  • Recherche et compilation de la littérature et des essais cliniques
  • L'évaluation clinique après MEDDEV 2.7/1 Révision 4 (Partie 2)
  • Examiner et analyser les données pertinentes
  • Création d'un rapport d'évaluation clinique (structure, contenu)
  • Possibilités et limites utilisant un produit équivalent
  • Pierres d’achoppement typiques durant les audits
  • Est-il obligatoire de faire une évaluation clinique pour une approbation ?
  • Des études „suivi clinique post-commercialisation (PMCF) “ sont-elles nécessaires?
  • Importance de l'analyse des risques dans l'évaluation des données cliniques pour les dispositifs médicaux

Les données de formation

Date:  Le 29 mars 2017
Heure: De 13.30 à 16.45
Lieu : ARIAQ SA, Rue Galilée 5, 1400 Yverdon-les-Bains
Langue: Français, documents en Anglais
Frais : CHF 340.-
Contact Secretariat ARIAQ: Inscription par tel: +41 (0)24 423 96 50
  Inscription par E-Mail à: This email address is being protected from spambots. You need JavaScript enabled to view it.                                   

 

Les places sont limitées!

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The ISO 13485 certification of the ISS AG was successfully maintained. The auditor issued a thoroughly good report and recommends maintaining the ISO 13485 certification without corrective actions requirements. This...

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