REGULATIONS

Regulatory compliance made simple.

Satisfy Quality & Regulatory Requirements

FDA, Notified Bodies in the EU, and other regulators around the globe ensure product safety through rigorous reviews of submissions and followup audits. Have confidence in your regulatory strategy with LuminLogic. Use LuminLogic to Implement your regulatory strategy and prepare submissions.

LuminLogic is the platform for:
Regulatory strategy implementation capabilities
LuminLogic is a compliance software solution that gives you a competitive advantage by:
  • Facilitating access to pertinent information
  • Planning and digitizing your regulatory strategy
  • Communicating regulatory strategies with stakeholders
  • Determining the type of submission needed
Regulatory Submission Creation and Management
  • Enabling collaboration between Subject Matter Experts (SMEs) and Management
  • Developing and managing FDA, CE Marking and other medical product submissions
  • Storing and controlling all submission documents
  • Managing content related to product and submissions
Regulatory Submission Creation and Management
  • Storing and managing FDA and other regulatory correspondence
  • Preparing and managing regulatory responses
Adverse Event Reporting
  • Determining if the complaint is reportable
  • Managing and approving complaints
  • Determining the need for recall
Recall Management
  • Reviewing and approving Health Hazard Evaluations
  • Managing recall reports to FDA
  • Monitoring recall effectiveness
Regulatory Traceability Creation and Management
  • Identifying and tracing to applicable regulations
  • Documenting and maintaining traceability between product design and regulatory requirement
  • Identifying gaps and revisions based on regulatory updates
Product Registration and Listing Management
  • Managing MDUFA fee, establishment registration, and product listing scheduling
  • Storing all registration and listing evidence
Labeling Management
  • Reviewing and delineating labeling requirements
  • Collaborating with SMEs and management for label development
  • Approving and managing labeling
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