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Principes fondamentaux du processus de soumission des dispositifs médicaux à la FDA des États-Unis
Advanced Level

Principes fondamentaux du processus de soumission des dispositifs médicaux à la FDA des États-Unis

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  1. Enseignement et milieu universitaire
  2. Conformité
  3. Principes fondamentaux du pro...

Principes fondamentaux du processus de soumission des dispositifs médicaux à la FDA des États-Unis

Ce cours en ligne gratuit vous emmène sur la voie de la commercialisation des dispositifs médicaux conformément aux réglementations de la FDA américaine.
La FDA américaine a promulgué plusieurs réglementations et politiques pour les fabricants de dispositifs médicaux qui souhaitent commercialiser leurs dispositifs médicaux aux États-Unis. L'inscription �... La FDA américaine a promulgué plusieurs réglementations et politiques pour les fabricants de dispositifs médicaux qui souhaitent commercialiser leurs dispositifs médicaux aux États-Unis. L'inscription à ce cours en ligne vous familiarisera avec les bases de cette réglementation et vous aidera à comprendre les différentes voies de commercialisation. Vous obtiendrez également une brève introduction à la norme ISO 13485 et à la norme 21 CFR Part 820, les normes requises pour établir un système de gestion de la qualité dans l'industrie de la fabrication de dispositifs médicaux.
COURSE PUBLISHER Exoexcellence ConsultantsExpert provider of ISO management
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What You Will Learn In This Free Course

  • Explain the global framework concer...
  • Describe the major steps required t...
  • Define the term "value proposition"...
  • State the premarket requirements ne...
  • Explain the global framework concerned with the regulations of medical devices
  • Describe the major steps required to market a medical device
  • Define the term "value proposition" in the context of medical device marketing
  • State the premarket requirements needed to be fulfilled before placing a medical device into the US market
  • Recognize the main similarities and differences between ISO 13485 and 21 CFR Part 820
  • Outline the necessary resources for manufacturers regarding premarket submission
  • Discuss the processions for a medical device manufacturer after submitting their medical device to the FDA
  • Identify the essential regulatory and product testing components in the US medical device marketing context
  • Indicate the different marketing pathways the FDA sets to help medical device manufacturers market their medical devices
  • Distinguish the medical devices according to the risks they pose to the FDA
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Course Modules
Course Description
Alison Certificates
Module

Understanding the Medical Device Marketing - The US Pathway

This module teaches you about the basic steps of medical device marketing within the US regulatory environment. You will also learn about the marketing pathways as defined by the U... Read More This module teaches you about the basic steps of medical device marketing within the US regulatory environment. You will also learn about the marketing pathways as defined by the US FDA and the premarket requirements before submission. The module also highlights the major differences between ISO 13485 and 21 CFR Part 820. Read Less
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Learner Reviews & Feedback For Principes fondamentaux du processus de soumission des dispositifs médicaux à la FDA des États-Unis

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Jurie Wessels V. Alison Graduate
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comprehensive course
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Tara J. Alison Graduate
loved this course
If you need a comprehensive understanding of the medical device process, this is a good course.
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