Customer Complaint Handling Process for Medical Device

Do you know the importance of complaints? Its legal implications? Impact on Post-Market Surveillance? Complaint Handling plays an important role in the device industry and is a regulatory requirement as well as a risk-reduction imperative. Thus, it is extremely important to manage and resolve complaints per regulatory bodies’ guidelines and standards.

Medical device companies must establish a customer complaint-handling process to collect feedback on potential adverse events that must be reported to the FDA.

IZiel Approach for Detailed Complaint Handling

· IZiel would adopt & implement these steps to help you with compliant handling.

· Establish Complaints Handling System

· Initial Review and Evaluation

· Investigation of Failures

· Medical Device Reporting

· Records

IZiel helps companies to develop the mechanism of post-market activities. IZiel assists companies to document the complaints handling process and helps you to understand the objectives of complaint handling within the context of the overall Quality System and Corrective and Preventive Action (CAPA) subsystem.

IZiel works with medical device companies to effectively manage Complaints Handling, thereby, helping you provide better, safer, more effective & quality products.