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Medical Device Incident Reporting

Expert Medical Device Incident Reporting to Meet Complex Regulatory Demands in Mature and Developing Markets

ClinChoice advances patient safety using our understanding of medical device nuances and industry best practices to provide a thorough analysis and comprehensive documentation of reported adverse incidents.

We provide exceptional prowess at each stage of incident reporting management:

  • Intake
  • Triage
  • Data Entry
  • Quality Review
  • Medical Review
  • Submissions

The modular design of our offerings allows the selection of individual services or an end-to-end solution for adverse incident reporting and management in the early clinical trial phases to post-marketing surveillance.

Our specialists have proficiency in Argus, ARISg/LifeSphere Safety, and other safety databases. We enhance our medical device incident reporting management capabilities by providing the following services:

  • Medical Device Call Center (MDCC) Management for Follow Up
  • Automated Tracking of Open and Missing Incidents
  • Monitoring of Expedited Reporting and Reporting of Submission Status
  • Submission of Serious Adverse Incident Reports to Health Authorities
  • Quality Assurance