Global medical device complaint management market is expected to grow at a steady pace owing to various issues in the medical devices leading to the customer dissatisfaction. For instance, an incident of electrical malfunction in surgical ablation system may result in the serious injury or death of the patient that requires an immediate action. Thus, act as a driving factor behind the market growth.
In the United States, the Food and Drug Administration (FDA) receives some hundred thousand medical device reports (MDR) of suspected device- associated malfunctions, serious injuries, and deaths. However, obtaining sufficient details about the event from the users and internal employees along with the employee’s ability to use the process may limit the market growth during the forecast period.
Medical device complaint management is segmented on the basis of services. The services segment includes complaints log/intake, product surveillance & regulatory compliance, returned/ non-returned product analysis, and resolve & closure. The complaints log/intake segment is further segregated to receive complaints, classify the issue, and record issue. The product surveillance & regulatory compliance includes reportable/non-reportable, medical device vigilance/medical device reporting, and field action. The segment of returned/ non-returned product analysis is divided into complaint investigation, root cause analysis & testing, and corrective/preventive action. The resolve & closure segment is fragmented into complaint summary and customer letter creation.
The segment of product surveillance & regulatory compliance is anticipated to grow significantly over the forecast period. This is owing to the fact that the regulatory agencies and users of the medical devices are becoming less tolerant with the failure of the medical devices as it results in the serious injury, death or may harm the user. Also, the regulatory agencies are placing greater emphasis on Product surveillance to track product performance and manage compliance.
Based on the geography, the medical device complaint management market is segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East and Africa (MEA). The Asia Pacific region is anticipated to grow over the forecast period as there are numerous big companies that are managing the complaints associated with the medical devices which include TCS, IBM, Wipro, and many more.
The players operating in the medical device complaint management include IQVIA, Wipro, Tata Consulting Services, SAS, Sparta Systems, Paraxel International Corporation, QUMAS, AssurX, etQ, and MasterControl.
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