The global medical device complaint management market size is expected to reach USD 10.2 billion by 2026, according to a new report by Grand View Research, Inc. It is anticipated to register a CAGR of 7.6% during the forecast period. Increasing use of software to support the entire complaint management process is propelling the growth.
The transition from paper-based to digital system for tracking complaints is boosting growth of the market. Incidents are recorded and the data automatically drives the investigation and resolution workflow. Companies experience more complete documentation along with the reduction in the turnaround time. The complaints management solution provides advanced analytics and reporting tools for augmented management oversight. The software also streamlines the submissions with standard reporting for the EU, FDA, Japan, Health Canada, and Australia.
For instance, the U.S. FDA encourages consumers, patients, and healthcare professionals to give voluntary reports of important adverse events, and/or product issues to MedWatch, FDA’s Safety Information and Adverse Event Reporting Program or by means of the mobile app known as MedWatcher. The app radically simplifies and accelerates the process of reporting by providing users with a four-step form submitted electronically to the FDA.
Regulators are gradually concentrating on handling customer complaints, product safety, and device vigilance. This is not only true in developed countries, but also in emerging economies such as India. The Indian government introduced medical devices regulation program, Materiovigilance Programme of India (MvPI) with focus on safety data collection, synchronization of international laws, regulations, and standards encourages medical device organizations to evaluate their existing procedures of product development and post-marketing surveillance.
Further key findings from the report suggest:
- Product surveillance and regulatory compliance emerged as the largest segment owing to greater emphasis put on product surveillance by regulatory agencies
- North America held the largest market share in 2017 owing to stern regulatory requirements and heavy monetary fines in this region. All the device manufacturers, importers, and distributors are required to comply with the complaint and record requirement
- Some of the key players operating in the medical device complaint management market include IQVIA, Wipro, Tata Consulting Services, SAS, Sparta Systems, Parexel International Corporation, Biovia, AssurX, MasterControl, and Freyr.
Access full research report on global medical device complaint management market: www.grandviewresearch.com/industry-analysis/medical-device-complaint-management-market