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© 2019 par ADN AxDaNe 

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marKET Registration 3DExperience

Is an ENOVIA application of the Dassault System 3DExperience platform to manage folders of products release, device identification registration, and security event reporting throughout the lifecycle of the product.

  • Streamline and automate the regulatory document schedule, records management and approval processes,

  • Manage submissions and device identification data,

  • Manage adverse events, from evaluation reporting, throughout submissions to closing,

  • Keep up and share project information with team members on a single, secure platform,

  • Maintain traceability.

MARKET REGISTRATION ROLES :

 

Regulatory Request Administrator :

  • Manages request types, 

  • Manages  request queues.

Regulatory Lead :

  • Manages submission projects, project members, reviewers, issues, access to content, and more...

 

Regulatory Administrator :

  • Manages regulatory submission types, 

  • Creates submission templates.