Medical Device Complaint Handling

Medical Device Complaint Handling and Reporting

Medical device manufacturers must record and track customer complaints according to the Quality System Regulation (QSR) defined in 21 CFR Part 820. Additionally, FDA Part 803 regulations require firms that have received complaints of device malfunctions, serious injuries, or deaths to notify the FDA.  Sparta solutions helps companies consolidate complaints and link them to regulatory reporting methods such as eMDR and eMDV.  They also reduces product safety risks and streamline workflow processes helping to improve overall quality. 

Benefits of Complaint & Regulatory Reporting Management

  • Improves management of the complaint handling lifecycle with real-time data and escalation of customer complaints.  
  • Automates the process of assigning complaints and related investigations based on manufacturing location, product type or other established customer complaint criteria.
  • Utilizes decision trees to help drive complaint management investigations and determine regulatory requirements around the world.  
  • Provides a validated environment compliant with the FDA, European Medicines Agency, and other agencies. 
  • Automates the eMDR and eMDV process by leveraging industry-standard EDI technology and reduces effort to comply with government mandates. 
  • Integrates with existing CRM systems to ensure automatic capture of complaints and feedback of investigation status. 
  • Consolidates and improves regulatory assessments and medical device reporting with integrated decision trees and the ability to generate and submit MedWatch forms electronically using electronic medical device report (eMDR) functionality. 
  • Reduces administrative costs with integrated letter generation, product return tracking and improved complaints workflow management. 

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