Medical Device Regulation in the USA (FDA) - Ref. SA15

Preparation of 510 (k) submissions

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Inter entreprise
Intra entreprise
Anglais sur demande

Avis de nos clients en 2018 : satisfaction générale 100 % | utilité de la formation 100%

Objectifs

Understand the regulatory process to obtain a market authorization for medical devices in USA under a 510 (k) “Premarket notification”
Familiarize with the content and format of 510 (k) submission dossiers

Programme

Public et niveau requis

Audience

  • Medical Device Manufacturers
  • Quality Affairs
  • Regulatory Affairs
  • R&D Engineers

Prerequisites

  • None

Les plus de la formation

FDA websites

Case studies

The speaker’s great experience of US and 510 (k) submissions

Moyens pédagogiques et modalités d'évaluation

Materials and teaching resources

  • Presentation slides
  • FDA websites
  • Case studies
  • Full binder with presentation slides
  • Session survey
  • Break and lunches with all participants to share experiences and learn

Evaluation procedures

  • Corrected exercices
  • A customer satisfaction questionnaire is given at the end of the training
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