Complaints and Mandatory Problem Reporting

Complaints

The Medical Device Regulations require that you have established procedures in place for complaints and mandatory problem reporting. If you sell medical devices, and you currently don’t have established procedures for these activities, then DSA can develop programs for you, which meet regulatory requirements.

If you don’t have resources on staff to assist you with investigations into quality complaints, then DSA can provide you with this expertise. We can review complaints, spearhead the investigation into the complaints, either directly or by dealing with your fabricators, and then ensure that the complaint can be closed out and resolved.

Mandatory Problem Reporting

The Medical Device Regulations outline specific requirements for mandatory problem reporting to Health Canada. A mandatory problem report is defined as:

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

DSA can help you develop protocols which delineate your responsibilities for reporting, if and when, device related failures occur.

DSA can help you determine if your complaints meet the requirements for mandatory problem reporting. If your device related failure does meet the requirements for mandatory problem reporting, DSA can prepare the filings on your behalf. We can also assist you with the investigation and advise you on whether or not your investigations are sufficient.

Contact us, to find out more information on Complaints and Mandatory Problem Reporting and how DSA can be of assistance to you. Or click here, to receive our free brochure.