Product Code: GVR-2-68038-783-4
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.
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.
Table of Contents
Chapter 1. Methodology and Scope
- 1.1. Market segmentation & scope
- 1.1.1. Segment definitions
- 1.2. Estimates and forecast timeline
- 1.3. Research methodology
- 1.4. Information procurement
- 1.4.1. Purchased database
- 1.4.2. GVR's internal database
- 1.4.3. Secondary sources
- 1.4.4. Primary research
- 1.4.5. Details of primary research
- 1.4.6. Research assumption
- 1.5. Information or data analysis
- 1.5.1. Data analysis models
- 1.6. Market formulation & data visualization
- 1.7. Model details
- 1.7.1. Commodity flow analysis
- 1.8. Objectives
- 1.8.1. Objective - 1
- 1.8.2. Objective - 2
- 1.8.3. Objective - 3
- 1.9. List of secondary sources
Chapter 2. Executive Summary
- 2.1. Medical device complaint management market
- 2.1.1. Market snapshot
- 2.1.2. Segment snapshot
- 2.1.2.1. Service type segment outlook
- 2.1.3. Competitive landscape snapshot
Chapter 3. Market Variables, Trends, & Scope
- 3.1. Market lineage outlook
- 3.1.1. Parent market outlook
- 3.1.2. Related/ancillary market outlook
- 3.2. Market trends and outlook
- 3.3. Market dynamics
- 3.3.1. Market driver analysis
- 3.3.1.1. The growing stringent regulatory compliance
- 3.3.1.2. Increasing digitalization in healthcare
- 3.3.1.3. Increased awareness of patient safety
- 3.3.2. Market restraint analysis
- 3.3.2.1. Rising misclassification of complaints
- 3.3.2.2. Inadequate training for staff
- 3.4. Regulatory framework
- 3.5. Business environment analysis tools
- 3.5.1. Industry analysis - Porter's five forces analysis
- 3.5.1.1. Supplier power
- 3.5.1.2. Buyer power
- 3.5.1.3. Substitution threat
- 3.5.1.4. Threat of new entrant
- 3.5.1.5. Competitive rivalry
- 3.5.2. PESTLE analysis
Chapter 4. Treatment Business Analysis
- 4.1. Medical device complaint management: treatment movement analysis
- 4.2. Medical device complaint management: treatment segment dashboard
- 4.3. Treatment movement & market share analysis, 2024 & 2030
- 4.4. Medical device complaint management estimates & forecast, by treatment
- 4.5. Complaints log / intake
- 4.5.1. Complaints log / intake market, 2018 - 2030 (USD Million)
- 4.5.2. Receive complaints
- 4.5.2.1. Receive complaints market, 2018 - 2030 (USD Million)
- 4.5.3. Classify the issue
- 4.5.3.1. Classify the issue market, 2018 - 2030 (USD Million)
- 4.5.4. Record issue
- 4.5.4.1. Record issue market, 2018 - 2030 (USD Million)
- 4.6. Product surveillance & regulatory compliance
- 4.6.1. Product surveillance & regulatory compliance market, 2018 - 2030 (USD Million)
- 4.6.2. Reportable/non-reportable
- 4.6.2.1. Reportable/non-reportable market, 2018 - 2030 (USD Million)
- 4.6.3. Medical device vigilance/medical device reporting
- 4.6.3.1. Medical device vigilance/medical device reporting market, 2018 - 2030 (USD Million)
- 4.6.4. Field action
- 4.6.4.1. Field action market, 2018 - 2030 (USD Million)
- 4.7. Returned/ non-returned product analysis
- 4.7.1. Returned/ non-returned product analysis market, 2018 - 2030 (USD Million)
- 4.7.2. Complaint investigation
- 4.7.2.1. Complaint investigation market, 2018 - 2030 (USD Million)
- 4.7.3. Root cause analysis, testing
- 4.7.3.1. Root cause analysis, testing market, 2018 - 2030 (USD Million)
- 4.7.4. Corrective/preventive action
- 4.7.4.1. Corrective/preventive action market, 2018 - 2030 (USD Million)
- 4.8. Resolve & closure
- 4.8.1. Resolve & closure market, 2018 - 2030 (USD Million)
- 4.8.2. Complaint summary
- 4.8.2.1. Complaint summary market, 2018 - 2030 (USD Million)
- 4.8.3. Customer letter creation
- 4.8.3.1. Customer letter creation market, 2018 - 2030 (USD Million)
Chapter 5. Medical Device Complaint Management: Regional Analysis
- 5.1 Regional Outlook
- 5.2 North America
- 5.2.1 North America medical device complaint management, 2018 - 2030 (USD Million)
- 5.2.2 U.S.
- 5.2.2.1 Key country dynamics
- 5.2.2.2 Regulatory framework
- 5.2.2.3 Competitive scenario
- 5.2.2.4 U.S. medical device complaint management market, 2018 - 2030 (USD Million)
- 5.2.3 Canada
- 5.2.3.1 Key country dynamics
- 5.2.3.2 Regulatory framework
- 5.2.3.3 Competitive scenario
- 5.2.3.4 Canada medical device complaint management market, 2018 - 2030 (USD Million)
- 5.2.4 Mexico
- 5.2.4.1 Key country dynamics
- 5.2.4.2 Regulatory framework
- 5.2.4.3 Competitive scenario
- 5.2.4.4 Mexico medical device complaint management market, 2018 - 2030 (USD Million)
- 5.3 Europe
- 5.3.1 Europe medical device complaint management, 2018 - 2030 (USD Million)
- 5.3.2 UK
- 5.3.2.1 Key country dynamics
- 5.3.2.2 Regulatory framework
- 5.3.2.3 Competitive scenario
- 5.3.2.4 UK medical device complaint management market, 2018 - 2030 (USD Million)
- 5.3.3 Germany
- 5.3.3.1 Key country dynamics
- 5.3.3.2 Regulatory framework
- 5.3.3.3 Competitive scenario
- 5.3.3.4 Germany medical device complaint management market, 2018 - 2030 (USD Million)
- 5.3.4 France
- 5.3.4.1 Key country dynamics
- 5.3.4.2 Regulatory framework
- 5.3.4.3 Competitive scenario
- 5.3.4.4 France medical device complaint management market, 2018 - 2030 (USD Million)
- 5.3.5 Italy
- 5.3.5.1 Key country dynamics
- 5.3.5.2 Regulatory framework
- 5.3.5.3 Competitive scenario
- 5.3.5.4 Italy medical device complaint management market, 2018 - 2030 (USD Million)
- 5.3.6 Spain
- 5.3.6.1 Key country dynamics
- 5.3.6.2 Regulatory framework
- 5.3.6.3 Competitive scenario
- 5.3.6.4 Spain medical device complaint management market, 2018 - 2030 (USD Million)
- 5.3.5 Norway
- 5.3.5.1 Key country dynamics
- 5.3.5.2 Regulatory framework
- 5.3.5.3 Competitive scenario
- 5.3.5.4 Norway medical device complaint management market, 2018 - 2030 (USD Million)
- 5.3.8 Sweden
- 5.3.8.1 Key country dynamics
- 5.3.8.2 Regulatory framework
- 5.3.8.3 Competitive scenario
- 5.3.8.4 Sweden medical device complaint management market, 2018 - 2030 (USD Million)
- 5.3.9 Denmark
- 5.3.9.1 Key country dynamics
- 5.3.9.2 Regulatory framework
- 5.3.9.3 Competitive scenario
- 5.3.9.4 Denmark medical device complaint management market, 2018 - 2030 (USD Million)
- 5.4 Asia Pacific
- 5.4.1 Asia Pacific medical device complaint management, 2018 - 2030 (USD Million)
- 5.4.2 Japan
- 5.4.2.1 Key country dynamics
- 5.4.2.2 Regulatory framework
- 5.4.2.3 Competitive scenario
- 5.4.2.4 Japan medical device complaint management market, 2018 - 2030 (USD Million)
- 5.4.3 China
- 5.4.3.1 Key country dynamics
- 5.4.3.2 Regulatory framework
- 5.4.3.3 Competitive scenario
- 5.4.3.4 China medical device complaint management market, 2018 - 2030 (USD Million)
- 5.4.4 India
- 5.4.4.1 Key country dynamics
- 5.4.4.2 Regulatory framework
- 5.4.4.3 Competitive scenario
- 5.4.4.4 India medical device complaint management market, 2018 - 2030 (USD Million)
- 5.4.5 Australia
- 5.4.5.1 Key country dynamics
- 5.4.5.2 Regulatory framework
- 5.4.5.3 Competitive scenario
- 5.4.5.4 Australia medical device complaint management market, 2018 - 2030 (USD Million)
- 5.4.6 South Korea
- 5.4.6.1 Key country dynamics
- 5.4.6.2 Regulatory framework
- 5.4.6.3 Competitive scenario
- 5.4.6.4 South Korea medical device complaint management market, 2018 - 2030 (USD Million)
- 5.4.5 Thailand
- 5.4.5.1 Key country dynamics
- 5.4.5.2 Regulatory framework
- 5.4.5.3 Competitive scenario
- 5.4.5.4 Thailand medical device complaint management market, 2018 - 2030 (USD Million)
- 5.5 Latin America
- 5.5.1 Latin America medical device complaint management, 2018 - 2030 (USD Million)
- 5.5.2 Brazil
- 5.5.2.1 Key country dynamics
- 5.5.2.2 Regulatory framework
- 5.5.2.3 Competitive scenario
- 5.5.3.4 Brazil medical device complaint management market, 2018 - 2030 (USD Million)
- 5.5.3 Argentina
- 5.5.3.1 Key country dynamics
- 5.5.3.2 Regulatory framework
- 5.5.3.3 Competitive scenario
- 5.5.3.4 Argentina medical device complaint management market, 2018 - 2030 (USD Million)
- 5.6 Middle East & Africa (MEA)
- 5.6.1 MEA medical device complaint management, 2018 - 2030 (USD Million)
- 5.6.2 South Africa
- 5.6.2.1 Key country dynamics
- 5.6.2.2 Regulatory framework
- 5.6.2.3 Competitive scenario
- 5.6.2.4 South Africa medical device complaint management market, 2018 - 2030 (USD Million)
- 5.6.3 Saudi Arabia
- 5.6.3.1 Key country dynamics
- 5.6.3.2 Regulatory framework
- 5.6.3.3 Competitive scenario
- 5.6.3.4 Saudi Arabia medical device complaint management market, 2018 - 2030 (USD Million)
- 5.6.4 UAE
- 5.6.4.1 Key country dynamics
- 5.6.4.2 Regulatory framework
- 5.6.4.3 Competitive scenario
- 5.6.4.4 UAE medical device complaint management market, 2018 - 2030 (USD Million)
- 5.6.5 Kuwait
- 5.6.5.1 Key country dynamics
- 5.6.5.2 Regulatory framework
- 5.6.5.3 Competitive scenario
- 5.6.5.4 Kuwait medical device complaint management market, 2018 - 2030 (USD Million)
Chapter 6 Competitive Analysis
- 6.1 Participants' overview
- 6.1.1 Financial performance
- 6.1.2 Service benchmarking
- 6.1.3 Participant categorization
- 6.1.4 Company market position analysis
- 6.1.5 Company profiles/listing
- 6.1.5.1 IQVIA
- 6.1.5.1.1 Overview
- 6.1.5.1.2 Financial performance
- 6.1.5.1.3 Service benchmarking
- 6.1.5.1.4 Strategic initiatives
- 6.1.6.2 Wipro
- 6.1.6.2.1 Overview
- 6.1.6.2.2 Financial performance
- 6.1.6.2.3 Service benchmarking
- 6.1.6.2.4 Strategic initiatives
- 6.1.6.3 Tata Consultancy Services (TCS)
- 6.1.6.3.1 Overview
- 6.1.6.3.2 Financial performance
- 6.1.6.3.3 Service benchmarking
- 6.1.6.3.4 Strategic initiatives
- 6.1.6.4 MasterControl
- 6.1.6.4.1 Overview
- 6.1.6.4.2 Financial performance
- 6.1.6.4.3 Service benchmarking
- 6.1.6.4.4 Strategic initiatives
- 6.1.6.5 Biovia
- 6.1.6.5.1 Overview
- 6.1.6.5.2 Financial performance
- 6.1.6.5.3 Service benchmarking
- 6.1.6.5.4 Strategic initiatives
- 6.1.6.6 Freyr
- 6.1.6.6.1 Overview
- 6.1.6.6.2 Financial performance
- 6.1.6.6.3 Service benchmarking
- 6.1.6.6.4 Strategic initiatives
- 6.1.6.7. Sparta Systems
- 6.1.6.7.1 Overview
- 6.1.6.7.2 Financial performance
- 6.1.6.7.3 Service benchmarking
- 6.1.6.7.4 Strategic initiatives
- 6.1.6.8 SAS
- 6.1.6.8.1 Overview
- 6.1.6.8.2 Financial performance
- 6.1.6.8.3 Service benchmarking
- 6.1.6.8.4 Strategic initiatives
- 6.1.6.9 AssurX
- 6.1.6.9.1 Overview
- 6.1.6.9.2 Financial performance
- 6.1.6.9.3 Service benchmarking
- 6.1.6.9.4 Strategic initiatives
- 6.1.6.10 Parexel International Corporation
- 6.1.6.10.1 Overview
- 6.1.6.10.2 Financial performance
- 6.1.6.10.3 Service benchmarking
- 6.1.6.10.4 Strategic initiatives