Medical Device Complaint Management Market
Medical Device Complaint Management Market Size, Share & Trends Analysis Report by Type (Complaints Log/ Intake, Product Surveillance & Regulatory Compliance, Returned/Non-Returned Product Analysis, and Resolve & Closure), by Application (Small & Medium Enterprise and Large Enterprise), by End-User (Hospitals, Specialty Clinics, and Ambulatory Services) Forecast Period (2022-2028)
Medical device complaint management market is anticipated to grow at a significant CAGR of nearly 8.2% during the forecast period. The major factors that drive the growth of the market include the growing adoption of digitalization in all phases and the functionalities of the healthcare industry promoting market growth. For instance, in April 2020, Veeva Systems announced Veeva Vault product surveillance, a cloud application for medical devices, and diagnostics to simplify and standardize the postmarket surveillance process. Vault Product surveillance automates electronic health authority submissions seamlessly with proactive complaint handling for faster adverse event reporting.
Another factor includes the rising number of public and private partnerships and favorable government initiatives that are boosting the adoption rates of automated, digital systems in complaint management processes. For instance, in 2017, the medical device product tracking system (UTS) was a national health care investment in digitalization implemented by the Turkish Medicines and Medical Devices Agency (TITCK).
Furthermore, the COVID-19 pandemic has had a significant impact on medical device complaint management. The pandemic disrupted the normal functioning of healthcare systems, manufacturing cycles, and supply and demand chains. The pandemic also led to numerous product defects and failures due to delays in supply. However, the US FDA has approved several Emergency Use Authorizations (EUAs) for medical devices under section 564 of the Federal Food, Drug, and Cosmetic (FD&C) as a response to the COVID-19 pandemic. Therefore, the demand for medical device complaint management increased during the COVID-19 pandemic.
Segmental Outlook
The global medical device complaint management is segmented based on the type, application, and end-user. Based on the type, the market is segmented into complaints log/intake, product surveillance & regulatory compliance, returned/non-returned product analysis, and resolve & closure. Based on the application, the market is sub-segmented into small & medium enterprises, and large enterprises. Based on the end-user, the market is sub-segmented into hospitals, specialty clinics, and ambulatory services.
Among the type, the complaint log/intake process holds the prominent share in the forecast period. The complaint log/intake process segment is the pioneer stage of complaint management and portrays a gateway mechanism for preventive or corrective action activities. The complaint files are linked to the medical device reporting (MDR) event file since the complaint needs to be assessed and determined whether it is a reportable adverse event. Moreover, From May 2020, medical device manufacturers must capture and track complaints based on the quality system regulation (QSR), which has been defined in 21 CFR Part 820. The manufacturers, importers, and device user facilities report certain device-related adverse events and product problems to the FDA. The regulation specified that reports be filed on the FDA's MedWatch Form 3500A or an electronic equivalent.
Regional Outlook
The global Medical Device Complaint Management market is further segmented based on geography including North America (the US, and Canada), Europe (UK, Germany, Italy, Spain, France, and Others), Asia-Pacific (India, China, Japan, South Korea, and Others), and the Rest of the World (the Middle East & Africa, and Latin America).
Global Medical Device Complaint Management Market Growth by Region, 2022-2028
North American Region is Expected to Hold a Major Share in the Global Medical Device Complaint Management Market
North America is expected to hold a major share in the medical device complaint management market. The market is growing in this region mainly due to the stringent regulation imposed by the regulatory body regarding complaint handling and management in the healthcare sector. This is expected to drive the growth of the medical device complaint management software in the region.
Market Players Outlook
The major companies serving the global medical device complaint management market include IQVIA, Wipro, Tata Consultancy Services (TCS), MasterControl, Biovia, and Freyr. The market players are considerably contributing to the market growth by the adoption of various strategies including mergers and acquisitions, partnerships, collaborations, and geographical expansion, to stay competitive in the market. For instance, in 2020, Wipro launched Talosafe, an upgrade to the existing Smartance platform for PV.
The Report Covers
- Market value data analysis of 2021 and forecast to 2028.
- Annualized market revenues ($ million) for each market segment.
- Country-wise analysis of major geographical regions.
- Key companies operating in the global medical device complaint management market. Based on the availability of data, information related to new product launches, and relevant news is also available in the report.
- Analysis of business strategies by identifying the key market segments positioned for strong growth in the future.
- Analysis of market entry and market expansion strategies.
- Competitive strategies by identifying ‘who-stands-where’ in the market.
1. Report Summary
• Current Industry Analysis and Growth Potential Outlook
1.1. Research Methods and Tools
1.2. Market Breakdown
1.2.1. By Segments
1.2.2. By Region
2. Market Overview and Insights
2.1. Scope of the Report
2.2. Analyst Insight & Current Market Trends
2.2.1. Key Findings
2.2.2. Recommendations
2.2.3. Conclusion
3. Competitive Landscape
3.1. Key Company Analysis
3.2. QVIA
3.2.1. Overview
3.2.2. Financial Analysis
3.2.3. SWOT Analysis
3.2.4. Recent Developments
3.3. Wipro Ltd.
3.3.1. Overview
3.3.2. Financial Analysis
3.3.3. SWOT Analysis
3.3.4. Recent Developments
3.4. Tata Consultancy Services Ltd.
3.4.1. Overview
3.4.2. Financial Analysis
3.4.3. SWOT Analysis
3.4.4. Recent Developments
3.5. MasterControl, Inc.
3.5.1. Overview
3.5.2. Financial Analysis
3.5.3. SWOT Analysis
3.5.4. Recent Developments
3.6. Dassault Systèmes
3.6.1. Overview
3.6.2. Financial Analysis
3.6.3. SWOT Analysis
3.6.4. Recent Developments
3.7. Key Strategy Analysis
4. Market Segmentation
4.1. Global Medical Device Complaint Management Market by Type
4.1.1. Complaints Log/Intake
4.1.2. Product Surveillance & Regulatory Compliance
4.1.3. Returned/Non-Returned Product Analysis
4.1.4. Resolve & Closure
4.2. Global Medical Device Complaint Management Market by Application
4.2.1. Small & Medium Enterprise
4.2.2. Large Enterprise
4.3. Global Medical Device Complaint Management Market by End-User
4.3.1. Hospitals
4.3.2. Specialty Clinics
4.3.3. Ambulatory Services
5. Regional Analysis
5.1. North America
5.1.1. United States
5.1.2. Canada
5.2. Europe
5.2.1. UK
5.2.2. Germany
5.2.3. Italy
5.2.4. Spain
5.2.5. France
5.2.6. Rest of Europe
5.3. Asia-Pacific
5.3.1. China
5.3.2. India
5.3.3. Japan
5.3.4. South Korea
5.3.5. Rest of Asia-Pacific
5.4. Rest of the World
6. Company Profiles
6.1. AssurX
6.2. Cognizant
6.3. ComplianceOnline.com
6.4. Freyr
6.5. GENERIS GROUP
6.6. Greenlight Guru
6.7. HCL Technologies
6.8. Parexel International Corp.
6.9. SAS Institute
6.10. Sparta Systems Inc.
1. GLOBAL MEDICAL DEVICE COMPLAINT MANAGEMENT MARKET RESEARCH AND ANALYSIS BY TYPE, 2021-2028 ($ MILLION)
2. GLOBAL MEDICAL DEVICE COMPLAINT MANAGEMENT FOR COMPLAINTS LOG/INTAKE MARKET RESEARCH AND ANALYSIS BY REGION, 2021-2028 ($ MILLION)
3. GLOBAL MEDICAL DEVICE COMPLAINT MANAGEMENT FOR PRODUCT SURVEILLANCE & REGULATORY COMPLIANCE MARKET RESEARCH AND ANALYSIS BY REGION, 2021-2028 ($ MILLION)
4. GLOBAL MEDICAL DEVICE COMPLAINT MANAGEMENT FOR RETURNED/NON-RETURNED PRODUCT MARKET RESEARCH AND ANALYSIS BY REGION, 2021-2028 ($ MILLION)
5. GLOBAL MEDICAL DEVICE COMPLAINT MANAGEMENT FOR RESOLVE & CLOSURE MARKET RESEARCH AND ANALYSIS BY REGION, 2021-2028 ($ MILLION)
6. GLOBAL MEDICAL DEVICE COMPLAINT MANAGEMENT MARKET RESEARCH AND ANALYSIS BY APPLICATION, 2021-2028 ($ MILLION)
7. GLOBAL MEDICAL DEVICE COMPLAINT MANAGEMENT IN SMALL & MEDIUM ENTERPRISE MARKET RESEARCH AND ANALYSIS BY REGION, 2021-2028 ($ MILLION)
8. GLOBAL MEDICAL DEVICE COMPLAINT MANAGEMENT IN LARGE ENTERPRISE MARKET RESEARCH AND ANALYSIS BY REGION, 2021-2028 ($ MILLION)
9. GLOBAL MEDICAL DEVICE COMPLAINT MANAGEMENT MARKET RESEARCH AND ANALYSIS BY END-USER, 2021-2028 ($ MILLION)
10. GLOBAL MEDICAL DEVICE COMPLAINT MANAGEMENT FOR HOSPITALS MARKET RESEARCH AND ANALYSIS BY REGION, 2021-2028 ($ MILLION)
11. GLOBAL MEDICAL DEVICE COMPLAINT MANAGEMENT FOR SPECIALTY CLINICS MARKET RESEARCH AND ANALYSIS BY REGION, 2021-2028 ($ MILLION)
12. GLOBAL MEDICAL DEVICE COMPLAINT MANAGEMENT FOR AMBULATORY SERVICES MARKET RESEARCH AND ANALYSIS BY REGION, 2021-2028 ($ MILLION)
13. GLOBAL MEDICAL DEVICE COMPLAINT MANAGEMENT MARKET RESEARCH AND ANALYSIS BY REGION, 2021-2028 ($ MILLION)
14. NORTH AMERICAN MEDICAL DEVICE COMPLAINT MANAGEMENT MARKET RESEARCH AND ANALYSIS BY COUNTRY, 2021-2028 ($ MILLION)
15. NORTH AMERICAN MEDICAL DEVICE COMPLAINT MANAGEMENT MARKET RESEARCH AND ANALYSIS BY TYPE, 2021-2028 ($ MILLION)
16. NORTH AMERICAN MEDICAL DEVICE COMPLAINT MANAGEMENT MARKET RESEARCH AND ANALYSIS BY APPLICATION, 2021-2028 ($ MILLION)
17. NORTH AMERICAN MEDICAL DEVICE COMPLAINT MANAGEMENT MARKET RESEARCH AND ANALYSIS BY END-USER, 2021-2028 ($ MILLION)
18. EUROPEAN MEDICAL DEVICE COMPLAINT MANAGEMENT MARKET RESEARCH AND ANALYSIS BY COUNTRY, 2021-2028 ($ MILLION)
19. EUROPEAN MEDICAL DEVICE COMPLAINT MANAGEMENT MARKET RESEARCH AND ANALYSIS BY TYPE, 2021-2028 ($ MILLION)
20. EUROPEAN MEDICAL DEVICE COMPLAINT MANAGEMENT MARKET RESEARCH AND ANALYSIS BY APPLICATION, 2021-2028 ($ MILLION)
21. EUROPEAN MEDICAL DEVICE COMPLAINT MANAGEMENT MARKET RESEARCH AND ANALYSIS BY END-USER, 2021-2028 ($ MILLION)
22. ASIA-PACIFIC MEDICAL DEVICE COMPLAINT MANAGEMENT MARKET RESEARCH AND ANALYSIS BY COUNTRY, 2021-2028 ($ MILLION)
23. ASIA-PACIFIC MEDICAL DEVICE COMPLAINT MANAGEMENT MARKET RESEARCH AND ANALYSIS BY TYPE, 2021-2028 ($ MILLION)
24. ASIA-PACIFIC MEDICAL DEVICE COMPLAINT MANAGEMENT MARKET RESEARCH AND ANALYSIS BY APPLICATION, 2021-2028 ($ MILLION)
25. ASIA-PACIFIC MEDICAL DEVICE COMPLAINT MANAGEMENT MARKET RESEARCH AND ANALYSIS BY END-USER, 2021-2028 ($ MILLION)
26. REST OF THE WORLD MEDICAL DEVICE COMPLAINT MANAGEMENT MARKET RESEARCH AND ANALYSIS BY COUNTRY, 2021-2028 ($ MILLION)
27. REST OF THE WORLD MEDICAL DEVICE COMPLAINT MANAGEMENT MARKET RESEARCH AND ANALYSIS BY TYPE, 2021-2028 ($ MILLION)
28. REST OF THE WORLD MEDICAL DEVICE COMPLAINT MANAGEMENT MARKET RESEARCH AND ANALYSIS BY APPLICATION, 2021-2028 ($ MILLION)
29. REST OF THE WORLD MEDICAL DEVICE COMPLAINT MANAGEMENT MARKET RESEARCH AND ANALYSIS BY END-USER, 2021-2028 ($ MILLION)
1. GLOBAL MEDICAL DEVICE COMPLAINT MANAGEMENT MARKET SHARE BY TYPE, 2021 VS 2028 (%)
2. GLOBAL MEDICAL DEVICE COMPLAINT MANAGEMENT FOR COMPLAINTS LOG/INTAKE MARKET SHARE BY REGION, 2021 VS 2028 (%)
3. GLOBAL MEDICAL DEVICE COMPLAINT MANAGEMENT FOR PRODUCT SURVEILLANCE & REGULATORY COMPLIANCE MARKET SHARE BY REGION, 2021 VS 2028 (%)
4. GLOBAL MEDICAL DEVICE COMPLAINT MANAGEMENT FOR RETURNED/NON-RETURNED PRODUCT ANALYSIS MARKET SHARE BY REGION, 2021 VS 2028 (%)
5. GLOBAL MEDICAL DEVICE COMPLAINT MANAGEMENT FOR RESOLVE & CLOSURE MARKET SHARE BY REGION, 2021 VS 2028 (%)
6. GLOBAL MEDICAL DEVICE COMPLAINT MANAGEMENT MARKET SHARE BY APPLICATION, 2021 VS 2028 (%)
7. GLOBAL MEDICAL DEVICE COMPLAINT MANAGEMENT IN SMALL & MEDIUM ENTERPRISE MARKET SHARE BY REGION, 2021 VS 2028 (%)
8. GLOBAL MEDICAL DEVICE COMPLAINT MANAGEMENT IN LARGE ENTERPRISE MARKET SHARE BY REGION, 2021 VS 2028 (%)
9. GLOBAL MEDICAL DEVICE COMPLAINT MANAGEMENT MARKET SHARE BY END-USER, 2021 VS 2028 (%)
10. GLOBAL MEDICAL DEVICE COMPLAINT MANAGEMENT FOR HOSPITALS MARKET SHARE BY REGION, 2021 VS 2028 (%)
11. GLOBAL MEDICAL DEVICE COMPLAINT MANAGEMENT FOR SPECIALTY CLINICS MARKET SHARE BY REGION, 2021 VS 2028 (%)
12. GLOBAL MEDICAL DEVICE COMPLAINT MANAGEMENT FOR AMBULATORY SERVICES MARKET SHARE BY REGION, 2021 VS 2028 (%)
13. GLOBAL MEDICAL DEVICE COMPLAINT MANAGEMENT MARKET SHARE BY REGION, 2021 VS 2028 (%)
14. US MEDICAL DEVICE COMPLAINT MANAGEMENT MARKET SIZE, 2021-2028 ($ MILLION)
15. CANADA MEDICAL DEVICE COMPLAINT MANAGEMENT MARKET SIZE, 2021-2028 ($ MILLION)
16. UK MEDICAL DEVICE COMPLAINT MANAGEMENT MARKET SIZE, 2021-2028 ($ MILLION)
17. FRANCE MEDICAL DEVICE COMPLAINT MANAGEMENT MARKET SIZE, 2021-2028 ($ MILLION)
18. GERMANY MEDICAL DEVICE COMPLAINT MANAGEMENT MARKET SIZE, 2021-2028 ($ MILLION)
19. ITALY MEDICAL DEVICE COMPLAINT MANAGEMENT MARKET SIZE, 2021-2028 ($ MILLION)
20. SPAIN MEDICAL DEVICE COMPLAINT MANAGEMENT MARKET SIZE, 2021-2028 ($ MILLION)
21. REST OF EUROPE MEDICAL DEVICE COMPLAINT MANAGEMENT MARKET SIZE, 2021-2028 ($ MILLION)
22. INDIA MEDICAL DEVICE COMPLAINT MANAGEMENT MARKET SIZE, 2021-2028 ($ MILLION)
23. CHINA MEDICAL DEVICE COMPLAINT MANAGEMENT MARKET SIZE, 2021-2028 ($ MILLION)
24. JAPAN MEDICAL DEVICE COMPLAINT MANAGEMENT MARKET SIZE, 2021-2028 ($ MILLION)
25. SOUTH KOREA MEDICAL DEVICE COMPLAINT MANAGEMENT MARKET SIZE, 2021-2028 ($ MILLION)
26. REST OF ASIA-PACIFIC MEDICAL DEVICE COMPLAINT MANAGEMENT MARKET SIZE, 2021-2028 ($ MILLION)
27. REST OF THE WORLD MEDICAL DEVICE COMPLAINT MANAGEMENT MARKET SIZE, 2021-2028 ($ MILLION)
