• Complaint system procedures. We integrate product development documentation and data sets into the complaint reporting and analysis systems.
  • Complaint and medical reviews
  • Procedures for Health Hazard Evaluations (HHE)
  • Medical officer review for HHE.
  • Recall management. We have global experience in Class II and Class III medical device recalls. These do not have to be fatal to your business. We can help you manage these successfully with an emphasis on patient protection and clear communication with cusotmers.