Medical Device Complaint Management Market To Reach $13.33 Billion By 2030

Medical Device Complaint Management Market Growth & Trends

The global medical device complaint management market size is estimated to reach USD 13.33 billion by 2030, registering a CAGR of 8.79% from 2025 to 2030, according to a new report by Grand View Research, Inc. Increasing utilization of software aiding in the overall complaint management process is expected to increase the market growth. The growing adoption of the digital system over paper-based work for tracking medical complaints is further boosting the market growth.

The medical device industry is highly regulated and inadequate product complaint handling accounts for a large percentage of FDA inspection findings. The complaints create severe reputational and brand risks and they need to be officially documented, inspected, tracked, and closed. Complaints may be minor, but they may also include a potential risk to the safety of the patient or product function or quality, which could cause damage to the company. Thus, it is important that all the complaints are correctly recorded in automated and integrated complaint management solutions to ensure that they are accurately investigated and addressed.

An increase in the demand for medical complaint management solutions has been registered over the past few years owing to the streamlined process. Incidents are recorded and the data automatically drives the investigation and resolution workflow. Companies are attaining complete medical documentation with minimal errors along with reduced turnaround time on the account of fact that complaint management solutions offer advanced analytics and reporting tools for augmented management oversight.

Moreover, the majority of companies are coming up with mobile app solutions to manage customer medical complaints. For instance, Intellect and Beckman Coulter in collaboration with Impiger technologies provide a mobile app platform on Google Play Store and the App Store to their customers, which enables them to register complaints, escalate tickets, and generate an inquiry. In addition, regulators are gradually focusing on handling customer complaints, the safety of the product, and device vigilance in both developed and emerging economies.

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Medical Device Complaint Management Market Report Highlights

• The market is expected to grow owing to an increase in the adoption of automated complaint filing systems over a paper-based system.

• By service type, the product surveillance and regulatory compliance segment emerged as the largest segment in 2024, owing to the fact that regulatory agencies and medical device users are increasingly focusing on product surveillance in order to avoid failure of the medical devices.

• North America dominated the market in 2024, owing to the presence of regulatory requirements in the region, coupled with the high incidence of medical device complaints witnessed over the past few years.

Medical Device Complaint Management Market Segmentation

Grand View Research has segmented the global medical device complaint management market based on service type, and region:

Medical Device Complaint Management Service Type Outlook (Revenue, USD Million, 2018 - 2030)

• Complaints Log / Intake

  • Receive Complaints

  • Classify the Issue

  • Record Issue

• Product Surveillance & Regulatory Compliance

  • Reportable/Non-Reportable

  • Medical Device Vigilance/Medical Device Reporting

  • Field Action

• Returned/ Non-Returned Product Analysis

  • Complaint Investigation

  • Root Cause Analysis, Testing

  • Corrective/Preventive Action

• Resolve & Closure

  • Complaint Summary

  • Customer Letter Creation

Medical Device Complaint Management Regional Outlook (Revenue, USD Million, 2018 - 2030)

• North America

  • U.S.

  • Canada

  • Mexico

• Europe

  • U.K

  • Germany

  • France

  • Italy

  • Spain

  • Denmark

  • Sweden

  • Norway

• Asia Pacific

  • China

  • Japan

  • India

  • South Korea

  • Australia

  • Thailand

• Latin America

  • Brazil

  • Argentina

• Middle East and Africa (MEA)

  • South Africa

  • Saudi Arabia

  • UAE

  • Kuwait

List of Key Players of Medical Device Complaint Management Market

• IQVIA

• Wipro

• Tata Consultancy Services (TCS)

• MasterControl

• Biovia

• Freyr

• Sparta Systems

• SAS

• AssurX

• Parexel International Corporation