Medical Device Complaint Management Market Size, Share, Growth, and Industry Analysis, By Type (Product Surveillance & Regulatory Compliance, Returned/Non-Returned Product Analysis, Resolve & Closure), By Application (Small & Medium Enterprise, Large Enterprise), Regional Insights and Forecast From 2025 To 2033

• 

  Request a Free sample to learn more about this report

MEDICAL DEVICE COMPLAINT MANAGEMENT MARKET OVERVIEW

Global medical device complaint management size was forecasted to be worth USD 5.98 billion in 2024, expected to achieve USD 9 billion by 2033 with a CAGR of 4.3% during the forecast period.

Managing medical device complaints is an important step in ensuring the safety and effectiveness of medical devices. This includes collecting, investigating and resolving complaints from customers, medical professionals and other sources. Rapid detection and correction of medical device problems is essential to protect patients and improve product quality. Complaint process involves multiple processes including receipt, documentation, evaluation, investigation and resolution of complaints.

Market growth is fueled by increasing adoption of digitization across all phases and functions of the healthcare industry. Market growth is supported by rapidly changing systems in complaint management from paper-based to digital solutions. Increasing public-private partnerships and positive government initiatives are increasing adoption of automated digital systems in grievance redressal processes.

COVID-19 IMPACT

Market Growth Restrained by Pandemic due to Supply Chain Disruptions

The global COVID-19 pandemic has been unprecedented and staggering, with the market experiencing lower-than-anticipated demand across all regions compared to pre-pandemic levels. The sudden market growth reflected by the rise in CAGR is attributable to market’s growth and demand returning to pre-pandemic levels.

The ongoing Covid-19 pandemic has seriously affected the normal functioning of healthcare systems and disrupted production cycles and demand and supply chains, and caused many product defects and failures.

LATEST TRENDS

Innovative Product Launch Offers Lucrative Opportunities

Medical Device Complaint Management key players are constantly working to develop new product development strategies to gain competitive advantage and meet growing market demand. For example, large companies create state-of-the-art mobile solutions to improve customer complaints. For example, Intellect provides a platform for integrated mobile applications that allow users to file complaints, escalate issues and create requests. The Intellect mobile app is conveniently located on the App Store and Google Play Store, where it can be downloaded as the Intellect mobile app or as a third-party mobile app.

Request a Free sample to learn more about this report

MEDICAL DEVICE COMPLAINT MANAGEMENT MARKET SEGMENTATION

By Type

Based on type the global market can be categorized into Product Surveillance & Regulatory Compliance, Returned/Non-Returned Product Analysis, Resolve & Closure.

• Product Surveillance & Regulatory Compliance: Regulatory agencies and customers will not tolerate adverse events, product defects, and medical devices that result in injury, damage, or death. Additionally, regulatory agencies are constantly focusing on the importance of product surveillance to closely monitor product performance and compliance. In the product surveillance segment, the product monitoring/medical device reporting segment is expected to register the fastest growth in the coming year.

• Returned/Non-Returned Product Analysis: Returned/non-returned product analysis examines the reasons for product returns and analyzes non-returned products.

• Resolve & Closure: Resolution and Closure focuses on handling and resolving customer complaints to ensure customer satisfaction. All these services help to effectively manage and handle customer complaints in the medical device industry.

By Application

Based on application the global market can be categorized into Small & Medium Enterprise, Large Enterprise.

• Small & Medium Enterprise: The Medical Device Complaint Management application is used by small and medium enterprises (SMEs) as well as large companies in the healthcare industry.

• Large Enterprise: SMEs refer to smaller companies with a limited number of employees, while large companies are significant organizations with more employees and resources. Both SMEs and large enterprises use complaint management solutions to handle customer complaints and improve quality control of medical devices. This helps with regulatory compliance, increases customer satisfaction and ensures patient safety.

DRIVING FACTORS

Growing Demand For Automated Organization Of The Grievance Procedure Will Boost The Market

The change from a paper-based structure to a digital structure due to the following complaints is an important factor of medical device complaint management market. Sympathetic government structural changes and growing demand for automated organization of the grievance procedure is driving the grievance redressal device market. Increasing the use of software to support the overall complaint handling process is an opportunity in the medical device complaint management market growth.

Increasing Focus On Quality Assurance Will Expand The Market

Focus on quality assurance is expected to drive the medical device complaint management market growth during the forecast period. Quality assurance is an important part of medical device complaint management. Several companies are developing intelligent quality methods to transform their quality assurance processes. They reengineer key quality processes that include automation and digitization and enable design thinking methodologies and new analytics to provide deep insight into process efficiency and product performance.

RESTRAINING FACTORS

Misclassification Of Medical Device Complaints Hinders Market Growth

Misclassification of complaints can lead to a never-ending cycle of worsening problems. It distorts trends, tracking and w. This is specifically scrutinized (and often flagged) by regulators as it can lead to MDR notifications not being delivered on time. In addition to creating a backlog, misclassification can make their removal difficult, requiring a time-consuming process of reopening and reviewing closed files.

• Request a Free sample to learn more about this report

•  

MEDICAL DEVICE COMPLAINT MANAGEMENT MARKET REGIONAL INSIGHTS

North America Dominating the Market due to Increasing Emphasis On Patient Safety And Stricter Regulatory Requirements

The market is primarily segregated into Europe, Latin America, Asia Pacific, North America, and Middle East & Africa.

The North American region accounted for the largest medical device complaint management market share in 2022 and is anticipated to continue to witness rapid growth during the forecast period. This is due to the region's increasing emphasis on patient safety and stricter regulatory requirements. Because of its strong regulatory framework, the United States is the largest medical device market in the world and requires the use of complaint management systems. In addition, an increase in adverse events and product reviews in the region is increasing interest in complaints. administrative organization. The introduction of cutting-edge innovations such as artificial intelligence and artificial intelligence is expected to stimulate the development of the market in the region. In addition, the presence of major market players and the increase in joint efforts and associations are expected to facilitate the development of the market.

KEY INDUSTRY PLAYERS

Key Industry Players Shaping the Market through Innovation and Market Expansion

The medical device complaint management market is significantly influenced by key industry players that play a pivotal role in driving market dynamics and shaping consumer preferences. These key players possess extensive retail networks and online platforms, providing consumers with easy access to a wide variety of options. Their strong global presence and brand recognition have contributed to increased consumer trust and loyalty, driving product adoption. Moreover, these industry giants continually invest in research and development, introducing innovative designs, materials, and smart features, catering to evolving consumer needs and preferences. The collective efforts of these major players significantly impact the competitive landscape and future trajectory of the market.

List of Top Medical Device Complaint Management Companies

• MasterControl (U.S.)
• Parexel International Corporation (U.S.)
• SAS (U.S.)
• Freyr (U.S.)
• AssurX (U.S.)
• Sparta Systems (U.S.)
• Wipro (India)
• Biovia (Japan)
• IQVIA (U.S.)
• Tata Consulting Services (India)

INDUSTRIAL DEVELOPMENT

September 2021: MasterControl has announced its complaint management solution. The solution is designed to help medical device manufacturers streamline their complaint management process from receipt to investigation and resolution. It includes features such as automated workflows, integrated risk management and advanced reporting capabilities.

REPORT COVERAGE

The study encompasses a comprehensive SWOT analysis and provides insights into future developments within the market. It examines various factors that contribute to the growth of the market, exploring a wide range of market categories and potential applications that may impact its trajectory in the coming years. The analysis takes into account both current trends and historical turning points, providing a holistic understanding of the market's components and identifying potential areas for growth.

The research report delves into market segmentation, utilizing both qualitative and quantitative research methods to provide a thorough analysis. It also evaluates the impact of financial and strategic perspectives on the market. Furthermore, the report presents national and regional assessments, considering the dominant forces of supply and demand that influence market growth. The competitive landscape is meticulously detailed, including market shares of significant competitors. The report incorporates novel research methodologies and player strategies tailored for the anticipated timeframe. Overall, it offers valuable and comprehensive insights into the market dynamics in a formal and easily understandable manner.