Complaints and Mandatory Problem Reporting

The Medical Device Regulations require that you have established procedures in place for complaints and handling investigations. Let Q&R Canada Inc. assist you in developing programs for your company that meet regulatory requirements.

Our team is experienced in handling investigations into quality complaints. We can review complaints, head the investigation by dealing with fabricators. We will provide continuous follow-up ensuring that the complaint is resolved quickly.

Mandatory problem reporting is required when a device related failure has led to the death or a serious deterioration in the state of health of a patient, user or other person, or could do so if it were to recur.

The Medical Device Regulations outline specific requirements for mandatory problem reporting to Health Canada and require that you have written procedures to address these requirements.

A Q&R consultant can help you:

  • Determine if your complaints meet the requirements for mandatory problem reporting
  • Assist with or perform the investigation
  • Manage the reporting process with Health Canada
Q&R Canada Canada Compliance, Product regulatory

Rely on Q&R Canada as your trusted partner for Canadian Regulatory Compliance. Working with you as your regulatory partner, we can and will provide exceptional, personalized and expert service as an integral component in building and protecting your company’s brand and profits.