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HCL Technologies

Complaint Handling for Medical Devices

Complaint Handling for Medical Devices

Medical device firms can make continuous improvements in user safety, regulatory compliance, and customer satisfaction by establishing a unique complaint handling process. The importance of complaint handling for medical devices is also emphasized by regulatory bodies around the globe. As per USFDA regulations, a complaint file should be maintained for every device launched in the market, and manufacturers should designate a formal complaint-handling unit.

It is seen that even with the well-defined requirements from different regulatory bodies, the number of complaints related observations keep increasing year on year. Implementation of an effective complaint handling process is a challenge for most of the organizations, especially if the products are sold in different geographies.

Having a flexible and a dynamic complaint handling process make organizations future-ready and efficient. This in turn can help them sustain their products in the market for a longer duration.