Medical Device Complaints Management Market

• Market poised for robust growth—the global medical device complaint management market was valued at approximately USD 8.08 billion in 2024 and is projected to reach USD 13.33 billion by 2030, reflecting a compound annual growth rate (CAGR) of 8.79% during the forecast period.

• North America leads regional demand&mdash>accounting for 44.6% of the global market share in 2024, driven by stringent regulatory requirements and advanced healthcare infrastructure.

• Product surveillance and regulatory compliance services dominate&mdash>with a share of over 56% in 2024, highlighting the critical importance of adhering to regulatory standards and ensuring patient safety.

• Complaint log/intake services exhibit fastest growth&mdash>projected to be the most lucrative services segment during the forecast period, driven by the increasing need for efficient complaint handling processes.

• Cloud-based delivery models gain traction&mdash>offering scalability, cost-effectiveness, and enhanced data security, leading to a shift from traditional on-premises solutions.

• Key players focus on innovation and compliance&mdash>companies like IQVIA, Wipro, Tata Consultancy Services (TCS), MasterControl, and Biovia are investing in advanced technologies and services to meet evolving regulatory requirements and improve complaint management processes.

• In September 2021, MasterControl introduced a complaint management solution to help medical device manufacturers streamline processes from receipt to investigation and resolution. Key features include automated workflows, integrated risk management, and advanced reporting capabilities.

• In 2024, Smarteeva launched an AI-driven complaint management and post-market surveillance solution for medical device manufacturers. The platform enables automated intake, decision-tree workflows, risk assessment, and seamless regulatory report generation.

In this report, the Medical Device Complaints Management Market has been segmented by Service, Application and Geography.

Medical Device Complaints Management Market, Segmentation by Service

The Service segmentation of the Medical Device Complaints Management Market comprises Complaints Log & Intake, Product Surveillance & Regulatory Compliance, Returned & Non-Returned Product Analysis, and Resolve & Closure. Each service category is essential for ensuring regulatory compliance, patient safety, and post-market surveillance. The rise in medical device recalls and increased vigilance from regulatory bodies such as the FDA and EMA has amplified demand for structured complaint management solutions globally.

Complaints Log & Intake

Complaints Log & Intake forms the foundation of the complaints management process, capturing detailed product feedback and incident reports. With the advent of AI-driven reporting systems and automated case triaging, companies are reducing turnaround times and improving traceability. This segment continues to grow as manufacturers prioritize digital integration with customer support platforms for seamless documentation.

Product Surveillance & Regulatory Compliance

Product Surveillance & Regulatory Compliance services ensure ongoing adherence to global quality management standards such as ISO 13485 and FDA 21 CFR Part 820. The increasing focus on post-market surveillance and vigilance reporting has driven manufacturers to outsource or automate compliance workflows. The segment is also expanding due to partnerships with regulatory technology firms providing real-time monitoring dashboards.

Returned & Non-Returned Product Analysis

Returned & Non-Returned Product Analysis involves root-cause evaluation of devices with reported issues, whether physically returned or not. This process is crucial for identifying manufacturing defects, usage errors, and field performance trends. The adoption of digital twin simulations and forensic engineering techniques is improving accuracy and helping companies prevent repeat complaints.

Resolve & Closure

Resolve & Closure ensures final resolution through corrective and preventive actions (CAPA) and detailed documentation for regulatory review. The implementation of cloud-based case tracking and cross-functional quality dashboards is enhancing resolution timelines. The segment is experiencing significant growth as companies aim for zero-defect manufacturing and proactive quality assurance.

Medical Device Complaints Management Market, Segmentation by Application

The Application segmentation consists of Small & Medium Enterprise and Large Enterprise. Market dynamics across these segments differ based on operational capacity, regulatory exposure, and technology adoption. The growing use of enterprise complaint management software and AI-driven compliance analytics is transforming how manufacturers of all sizes manage device performance feedback.

Small & Medium Enterprise

Small & Medium Enterprises (SMEs) are increasingly leveraging outsourced complaint handling services and SaaS-based compliance tools to remain cost-effective. Their focus lies in automating complaint intake and ensuring timely regulatory filings without maintaining large in-house teams. Rising pressure from global compliance standards has led to higher investment in integrated digital complaint management platforms.

Large Enterprise

Large Enterprises dominate the market due to their extensive product portfolios and global distribution networks. These organizations prioritize advanced data analytics, predictive risk management, and cross-regional complaint harmonization. Strategic partnerships with technology vendors are helping large enterprises streamline their global post-market surveillance operations and reduce regulatory penalties.

Medical Device Complaints Management Market, Segmentation by Geography

In this report, the Medical Device Complaints Management Market has been segmented by Geography into five regions: North America, Europe, Asia Pacific, Middle East and Africa and Latin America.

North America

North America leads the global market owing to stringent FDA post-market surveillance requirements and strong adoption of automated complaint management systems. The region is characterized by high investment in cloud-based quality management solutions and rapid technological innovation among leading device manufacturers.

Europe

Europe continues to exhibit steady growth, driven by the enforcement of the EU MDR regulations and enhanced focus on regulatory traceability and clinical safety. The presence of numerous medical device OEMs and regulatory consultants supports the development of specialized complaint analytics software across the region.

Asia Pacific

Asia Pacific is the fastest-growing regional market, driven by expanding manufacturing bases in China, India, and Japan and increasing awareness of quality and compliance management. The region’s growing integration of digital complaint reporting systems and emphasis on local regulatory harmonization contribute significantly to growth.

Middle East & Africa

Middle East & Africa are emerging markets where growing healthcare infrastructure and regulatory modernization initiatives are driving adoption. The focus on improving product safety and market surveillance capabilities is encouraging partnerships between regulators and medical device manufacturers.

Latin America

Latin America shows strong potential due to increasing medical device imports and national regulatory alignment with global standards. Countries such as Brazil and Mexico are prioritizing electronic vigilance systems and post-market reporting programs, positioning the region as an emerging hub for compliant device management practices.

This report provides an in depth analysis of various factors that impact the dynamics of Global Medical Device Complaint Management Market. These factors include; Market Drivers, Restraints and Opportunities Analysis.

Drivers, Restraints and Opportunity Analysis

Medical Device Complaints Management Market is characterized by increasing competition, with major players adopting advanced strategies to improve complaint resolution and ensure compliance. A significant focus on innovation in digital tracking tools and enhanced analytics has driven higher growth. More than 65% of leading providers emphasize partnerships to streamline reporting and strengthen regulatory alignment.

Market Structure and Concentration
The market reflects moderate concentration, where over 55% of revenue is contributed by top-tier providers integrating technological advancements. Consolidation through merger and collaboration creates stronger networks. This structure supports better cost efficiencies and fosters expansion into new service categories, aligning with strict regulatory and quality requirements.

Brand and Channel Strategies
Companies are refining strategies across digital and offline channels to ensure higher visibility and service reliability. Around 70% of players prioritize partnerships with software and healthcare intermediaries to accelerate adoption. Unified branding strengthens customer confidence, while diverse collaboration models facilitate wider expansion across institutional buyers.

Innovation Drivers and Technological Advancements
Nearly 60% of industry leaders invest in innovation focusing on AI-driven analytics, cloud-based complaint tracking, and secure data storage. These technological advancements elevate accuracy and speed of reporting. Strategic collaboration with IT vendors boosts integrated platforms, creating a future outlook of smarter and automated complaint management.

Regional Momentum and Expansion
Market penetration shows distinct regional trends, with over 50% of growth concentrated in high-regulation areas. Firms leverage expansion strategies combining local partnerships and global digital platforms. This regional momentum allows scalable operations, better collaboration, and adaptive solutions to match the compliance frameworks of each healthcare jurisdiction.

Future Outlook
The sector anticipates over 65% of investments to flow into digital-first platforms and integrated feedback loops. Rising emphasis on technological advancements and sustained innovation will define upcoming models. Stronger partnerships, evolving strategies, and continuous process improvement are expected to reinforce a positive future outlook for all key stakeholders.

Key players in Medical Device Complaint Management Market include:

• IQVIA
• Parexel
• SAS
• Wipro
• Tata Consulting Services
• Sparta Systems
• Freyr
• Biovia
• Assurx
• MasterControl

In this report, the profile of each market player provides following information:

• Market Share Analysis
• Company Overview and Product Portfolio
• Key Developments
• Financial Overview
• Strategies
• Company SWOT Analysis