With patient safety taking center stage in global healthcare, the medical device complaint management market is experiencing unprecedented growth. Valued at USD 8.09 billion in 2024, the market is projected to nearly double, reaching USD 18.62 billion by 2034, at a CAGR of 8.7% between 2025 and 2034. But what is fueling this momentum, and how could it reshape medical device oversight worldwide?
Complaint management software, an integral part of a Quality Management System (QMS), empowers manufacturers to promptly address safety concerns, track adverse events, and coordinate with suppliers. By capturing product-in-use data and feeding it back to design and engineering teams, these systems ensure continuous improvement in device performance and safety.
The integration of Complaint and Concern Management (CCM) modules enables real-time feedback loops, enhances supply chain efficiency, and ensures compliance with stringent regulatory frameworks.
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The U.S. FDA reported a sharp increase in medical device complaints, with 1.46 million reports in 2021, up 19.6% from 2020. This heightened vigilance, driven by stricter regulations and patient safety awareness, is propelling demand for robust complaint management solutions.
Governments and health authorities are imposing stricter post-market surveillance requirements, compelling manufacturers to adopt advanced complaint tracking tools to avoid penalties and maintain compliance.
Improper complaint classification remains a critical challenge. Mislabeling incidents can disrupt tracking trends, cause backlogs, and lead to unfiled MDRs (Medical Device Reports), attracting regulatory scrutiny and costly re-investigations.
Leading companies are innovating with mobile-based complaint management platforms. For instance, Intellect offers an app enabling users to submit complaints, escalate issues, and track resolutions directly from their smartphones—bridging gaps in accessibility and speed.
The lack of specialized training for risk assessment and ranking often results in inconsistent severity scoring. This gap demands skilled complaint handlers who understand both the technical device details and the complaint management software.
North America: Dominates due to advanced healthcare infrastructure and strict FDA compliance requirements.
Europe: Strong growth driven by patient safety regulations and vigilant post-market monitoring.
Asia-Pacific: Fastest-growing region thanks to booming healthcare investment in China, India, and Southeast Asia.
Latin America, Middle East & Africa: Gradual adoption, supported by evolving regulatory frameworks.
The market is highly competitive, with major players such as:
Freyr
IQVIA
Wipro
Sparta Systems
Oracle
Zendesk
These companies are expanding capabilities through product innovations, strategic partnerships, and cloud-based complaint tracking systems
June 2024: InfectoPharm adopted Sparta Systems’ TrackWise Digital® for integrated QMS processes, enhancing supplier and manufacturing oversight.
Nov 2024: IQVIA launched a grants and funding management module within its OCE suite, streamlining strategic healthcare initiatives.
As global regulations tighten and patient safety demands rise, the medical device complaint management market is poised for transformative growth. By 2034, advanced complaint tracking systems—powered by AI, mobile integration, and real-time analytics—could become the industry’s frontline defense against device-related risks.