According to FutureWise analysis, the medical device complaint management market in 2026 is US$8.49 billion, and is expected to reach US$15.83 billion by 2036 at a CAGR of 6.43%.
The medical device complaint management market is experiencing significant growth. This increase is primarily driven by stringent regulatory requirements from organizations such as the FDA, EMA, and other global health authorities, which mandate comprehensive complaint tracking and post-market surveillance systems. The growing complexity of medical devices, combined with increasing patient safety concerns, has made it essential for manufacturers to have robust complaint management systems. These systems help identify potential product defects and prevent adverse events. Healthcare organizations are increasingly adopting cloud-based and AI-powered complaint management solutions that streamline data collection, analysis, and reporting, while also ensuring compliance with evolving quality management standards. The rise in medical device recalls and product liability lawsuits has further highlighted the need for proactive complaint handling mechanisms that can quickly detect patterns and initiate corrective actions. Emerging markets in the Asia-Pacific and Latin America regions are seeing accelerated adoption of these systems as local manufacturers scale their operations and align with international quality standards to compete in the global marketplace. Additionally, the integration of advanced analytics and machine learning capabilities is transforming traditional complaint management into predictive quality intelligence systems. This transformation enhances product safety and operational efficiency throughout the medical device lifecycle.
Healthcare industry growth is being driven by the increasing adoption of digitalization in all phases and functionalities. The market growth is being facilitated by the rapid transition from paper-based to digital complaints management systems. As the number of PPPs and government initiatives increases, complaint management processes are being automated and digitized. These automated software solutions support better documentation of complaints. Data and information about complaints are collected using a multi-page electronic complaint form, which is then reorganized by the software solution into three steps: complaint processing, investigation, and resolution. The process is documented and computerized every step of the way. Additionally, the complaint management system provides advanced analytical solutions integrated with reporting tools, which could be used in augmented management oversight providing transparency that enhances decision-making processes.
FutureWise Market Research has instantiated a report that provides an intricate analysis of Medical Device Complaint Management Market trends that shall affect the overall market growth. Furthermore, it includes detailed information on the graph of profitability, SWOT analysis, market share and regional proliferation of this business. Moreover, the report offers insights on the current stature of prominent market players in the competitive landscape analysis of this market.
According to the research study conducted by FutureWise research analysts, the Medical Device Complaint Management Market is anticipated to attain substantial growth by the end of the forecast period. The report explains that this business is predicted to register a noteworthy growth rate over the forecast period. This report provides crucial information pertaining to the total valuation that is presently held by this industry and it also lists the segmentation of the market along with the growth opportunities present across this business vertical.