Regulatory Team Member

The ENOVIA 3DEXPERIENCE Regulatory Team Member (GLR) Role is a sophisticated, easy to use tool that helps produce submission-ready, quality content in a timely manner.

Regulatory Team Member manages global medical device market registrations, product identification processes and submissions throughout the product lifecycle. It evaluates and manages reportable safety events submissions to global health authorities.

ENOVIA Regulatory Team Member

Regulatory Team Member Benefits

Ensure Complete Control

Govern device registration process from planning, document gathering, compilation to submissions; tracking product registrations and managing interactions with the regulatory agencies; coordinating regulatory activities with a global plan and schedule for submission-ready deliverables in a timely manner.

Reduce Product Development Delays

Aggregate product Information on the 3DEXPERIENCE platform for single source of the truth as product change and evolve.

Improve Global Team Efficiency

Coordinate global activities for simply creating the submissions needed, managing dossiers, adding and reusing documents; regulatory teams are able to quickly identify all available, expected, in-process or missing submission documents by products, regions, or countries.

Speed Up Time to Market

Enterprise wide process for capturing, managing, approving and submitting device identification data. Govern Device Identification Records turning data into accessible product knowledge for submissions to FDA GUDID.

Reduce Issues Related to Adverse Event Tracking

Manage evaluation and reporting safety related adverse events to regulatory authorities from intake to decision trees and direct regulatory report generation to closure supporting eMDR submissions to the FDA.

ENOVIA Regulatory Submission

Regulatory Team Member Highlights

• Complete control of regulatory communications staying on top of all regulatory activities, from communications to renewals.
• Accelerate time-to-market by streamlining and automating the complete regulatory submission and approval process (dossier assembly through end of life).
• Manage end-to-end DI (device identifier) submission and global regulatory submission tracking for market approval.
• Track reported adverse events and manage them from initial triage through reporting and case closure to meet the complex and varying requirements of global regulatory authorities.

Included 3DEXPERIENCE Apps

• Adverse Event Reporting.
• Device Identification.
• Market Registration.
• My Submissions.