Monitoring the safety and effectiveness of your medical device after it has been commercialized requires the implementation of effective post-market processes and activities specifically designed to ensure the ongoing compliance of your product(s). Regulatory Compliance Associates® Inc. can help you design, implement, and execute a Post-Market Support Strategy including:

 

  • Corrective and Preventive Action (CAPA) Support
  • Root Cause Investigation
  • Audit / Inspection Preparation and Remediation
  • Labeling Review and Assessment
  • Post-Market Surveillance (PMS)
  • Medical Device Reporting / Adverse Event Reporting
  • Recall Management
  • Complaint Handling
  • Re-submission Assessment and Remediation

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