Medical Device Complaint Management Market
Medical Device Complaint Management Market Size, Share & Trends Analysis Report By Service Type (Product Surveillance & Regulatory Compliance, Complaint Log/Intake), By Region, And Segment Forecasts, 2022 to 2032
Analysis of Medical Device Complaint Management market covering 30 + countries including analysis of US, Canada, UK, Germany, France, Nordics, GCC countries, Japan, Korea and many more
Medical Device Complaint Management Market
The medical device complaint management market is expected to garner a market value of US$ 5.35 Bn in 2022, anticipated to register a positive CAGR of 7% in the forecast period 2022 to 2032 and reach a value of US$ 10.52 Bn.
Report Attributes | Details |
---|---|
Medical Device Complaint Management Market Size (2022) | US$ 5.35 Bn |
Sales Forecast for Medical Device Complaint Management (2032) | US$ 10.52 Bn |
Global Market Growth Rate (2022 to 2032) | 7% CAGR |
Key Companies Profiled | IQVIA; Parexel; SAS Institute; Wipro Limited; Tata Consultancy Services; Sparta Systems Inc.; Freyr Solutions; BIOVIA; AssurX; MasterControl Inc. |
Don't Need a Global Report?
save 40%! on Country & Region specific reports
Demand Analysis of Medical Device Complaint Management from 2015 to 2021 Vs Future Outlook 2022 to 2032
From 2015 to 2021, the global medical device complaint management market registered significant gains, reaching a valuation of US$ 5 Bn in 2021. According to Fact.MR- a market research and competitive intelligence provider- demand for medical device complaint management flourished at a CAGR of 6.7% during the said historical period.
The growing adoption of digitalization in all phases and functionalities of the healthcare industry is promoting the market growth. Rapidly transforming systems from paper-based to digital solutions in managing complaints are supporting the market growth. Prospects remained elevated even during the COVID-19 pandemic, as healthcare providers worked ceaselessly to contain the spread of infections, requiring them to reach out to medical device complaint management service providers, in case of ruptured or damaged equipment.
The rising number of public and private partnerships and favorable government initiatives are boosting the adoption rates of automated, digital systems in complaint management processes. Considering these factors, the market is projected to witness high growth over the coming years, anticipated to grow nearly 2x from 2022 to 2032.
What is driving the Market Demand for Medical Device Complaint Management?
Enhancement of Clinical Workflow for More Efficient Operation Increasing Uptake
The implementation of these automated software solutions supports enhanced documentation. By using a multi-page electronic form, complaint data and information are accurately and precisely captured and are reorganized by the software solution into a three-step program that comprises complaint processing, investigation, and resolution. Every step of this program is computerized and precisely documented.
Furthermore, the complaint management system offers advanced analytical solutions incorporated with reporting tools, which could be used in augmented management oversight providing required transparency that enhance the decision-making processes. Key participants are constantly focusing on devising innovative product development strategies to gain a competitive edge and cater to the growing demand in the market.
Increasing Government Support to Streamline Medical Workflow to Spur Demand
Favorable government initiatives are boosting the growth of the complaint management market. For instance, the U.S. FDA encourages patients, healthcare professionals, care providers, and consumers to voluntarily submit reports of product defects and/or adverse events to MedWatch, which is the U.S. FDA’s Safety Information and Adverse Event Reporting Program or then by using MedWatcher, the mobile application.
Moreover, adverse event reporting witnessed a surge in the number owing to the launch of the MedWatch. The MedWatch application simplifies and accelerates the complaint reporting process by offering customers an easy four-step form, which is to be electronically submitted to the U.S. FDA. Therefore, the development and launch of these innovative mobile applications in complaint management are expected to fuel the market growth.
More Insights, Lesser Cost (-50% off)
Insights on import/export production,
pricing analysis, and more – Only @ Fact.MR
Country-wise Analysis
How is the US Propelling Growth of Medical Device Complaint Management?
Mandatory Reporting Requirements of Medical Device Conditions to Encourage Uptake
According to Fact.MR, the U.S. holds the largest share in the North American market, both in terms of volume and revenue. The country is expected to maintain its lead in the market over the forecast period, accounting for a revenue share of over 40% due to the presence of stringent regulatory guidelines for complaint management.
For instance, in the U.S., the regulatory guidelines for MDR include compulsory requirements for manufacturers, importers/exporters, and user facilities in reporting adverse events and product failures related to medical devices directly to the U.S. FDA.
How is the German Market Performing?
Emphasis on improving existing Healthcare Infrastructure Driving Growth
The German market is anticipated to expand at a significant CAGR of 8.3% over the forecast period owing to the stringent regulations and mandatory requirements for medical device manufacturers to report adverse events and corresponding safety actions undertaken to the European regulatory authorities.
Manufacturers and companies failing to comply with these mandatory requirements could face hefty penalizations. The healthcare and life sciences industry is a priority for Germany as reflected in the European Regional Development Fund program and cohesion policy 2021 to 2027. The platform emphasizes on the need to incorporate advanced R&D in the medical industry.
With the presence of an already robust healthcare industry, especially with respect to infrastructure such as hospital beds and trained staff, strengthening of medical device complaint management systems will further solidify the country’s position in the global healthcare domain.
Category-wise Insights
Which Service Type Leads the Market?
High Focus to be given on Product Surveillance and Regulatory Compliance
The product surveillance and regulatory compliance segment dominates the market, accounting for a revenue share of over 55%. Regulatory agencies and customers are growing less tolerant of adverse events, product defects, and medical device failures since it results in injury, harm, or death. Furthermore, regulatory agencies are constantly focusing on the importance of product surveillance to precisely track product performance and compliance.
Under the product surveillance segment, the medical device vigilance/ medical device reporting segment is expected to register the fastest growth rate over the forthcoming years. This lucrative growth is attributed to regulatory reforms undertaken by regulatory authorities such as the U.S. FDA. For instance, the U.S. FDA has made it compulsory for firms to report any complaints regarding adverse events or product malfunctions and failures related to medical devices directly to the U.S. FDA. Non-compliance with these mandatory regulatory reforms would result in hefty penalizations.
The complaint log/intake segment is expected to register the fastest growth rate over the forthcoming years. This segment is the pioneer stage of complaint management and portrays a gateway mechanism for preventive or corrective action and post-market activities. 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, its compulsory for medical device manufacturers to capture and track complaints based on the quality system regulation (QSR), which has been defined in 21 CFR Part 820.
Know thy Competitors
Competitive landscape highlights only certain players
Complete list available upon request
Competitive Landscape
The competitive landscape of the medical device complaint management market is shaped by product innovation and strategic mergers & acquisitions. Front Runners are emphasizing capacity enhancements and global footprint expansion to leverage lucrative prospects in developing economies.
- In November 2021, IQVIA announced the launch of a new module of its Grants and Funding Management within its Orchestrated Customer Engagement (OCE) solutions portfolio. This initiation is expected to provide the life sciences industry with a solution to efficiently manage and oversee their global strategic giving programs
Medical Device Complaint Management Market Report Scope
Report Attributes | Details |
---|---|
Forecast Period | 2022 to 2032 |
Historical Data Available for | 2015 to 2021 |
Market Analysis | US$ Mn for Value |
Key Regions Covered | North America; Latin America; Europe; Asia Pacific; Middle East & Africa |
Key Countries Covered | U.S., Canada, Germany, U.K., France, Italy, BENELUX, Nordics, China, Japan, South Korea, GCC, Turkey, South Africa |
Key Market Segments Covered | Service Type, Region |
Key Segments Covered in Medical Device Complaint Management Industry Research
-
By Service Type
- Medical Device Complaints Log / Intake
- Receive Complaints
- Classify the Issue
- Record Issue
- Medical Device Product Surveillance & Regulatory Compliance
- Reportable/Non-reportable
- Medical Device Vigilance/Medical Device Reporting
- Field Action
- Returned/ Non-returned Medical Device Product Analysis
- Complaint Investigation
- Root Cause Analysis, Testing
- Corrective/Preventive Action
- Medical Device Complaints Resolve & Closure
- Complaint Summary
- Customer Letter Creation
- Medical Device Complaints Log / Intake
Table of Content
- 1. Executive Summary
- 2. Market Overview
- 3. Market Risks and Trends Assessment
- 4. Market Background and Foundation Data Points
- 5. Key Success Factors
- 6. Global Market Demand Analysis 2015 to 2021 and Forecast, 2022 to 2032
- 7. Global Market Value Analysis 2015 to 2021 and Forecast, 2022 to 2032
- 8. Global Market Analysis 2015 to 2021 and Forecast 2022 to 2032, By Service Type
- 8.1. Complaints Log / Intake
- 8.1.1. Receive Complaints
- 8.1.2. Classify the Issue
- 8.1.3. Record Issue
- 8.2. Product Surveillance & Regulatory Compliance
- 8.2.1. Reportable/Non-reportable
- 8.2.2. Medical Device Vigilance/Medical Device Reporting
- 8.2.3. Field Action
- 8.3. Returned/ Non-returned Product Analysis
- 8.3.1. Complaint Investigation
- 8.3.2. Root Cause Analysis, Testing
- 8.3.3. Corrective/Preventive Action
- 8.4. Resolve & Closure
- 8.4.1. Complaint Summary
- 8.4.2. Customer Letter Creation
- 8.1. Complaints Log / Intake
- 9. Global Market Analysis 2015 to 2021 and Forecast 2022 to 2032, By Region
- 9.1. North America
- 9.2. Latin America
- 9.3. Europe
- 9.4. Asia Pacific
- 9.5. Middle East and Africa (MEA)
- 10. North America Market Analysis 2015 to 2021 and Forecast 2022 to 2032
- 11. Latin America Market Analysis 2015 to 2021 and Forecast 2022 to 2032
- 12. Europe Market Analysis 2015 to 2021 and Forecast 2022 to 2032
- 13. Asia Pacific Market Analysis 2015 to 2021 and Forecast 2022 to 2032
- 14. Middle East and Africa Market Analysis 2015 to 2021 and Forecast 2022 to 2032
- 15. Key Countries Market Analysis 2015 to 2021 and Forecast 2022 to 2032
- 16. Market Structure Analysis
- 17. Competition Analysis
- 17.1. IQVIA
- 17.2. PAREXEL
- 17.3. SAS
- 17.4. WIPRO
- 17.5. TATA CONSULTING SERVICES
- 17.6. SPARTA SYSTEMS
- 17.7. FREYR
- 17.8. BIOVIA
- 17.9. ASSURX
- 17.10. MASTERCONTROL
- 18. Assumptions and Acronyms Used
- 19. Research Methodology
Don't Need a Global Report?
save 40%! on Country & Region specific reports
List Of Table
Table 1: Global Market Value (US$ Mn), By Service Type, 2015 to 2021
Table 2: Global Market Value (US$ Mn), By Service Type, 2022 to 2032
Table 3: Global Market, By Region, 2015 to 2021
Table 4: Global Market, By Region, 2022 to 2032
Table 5: North America Market Value (US$ Mn), By Service Type, 2015 to 2021
Table 6: North America Market Value (US$ Mn), By Service Type, 2022 to 2032
Table 7: North America Market, By Country, 2015 to 2021
Table 8: North America Market, By Country, 2022 to 2032
Table 9: Latin America Market Value (US$ Mn), By Service Type, 2015 to 2021
Table 10: Latin America Market Value (US$ Mn), By Service Type, 2022 to 2032
Table 11: Latin America Market, By Country, 2015 to 2021
Table 12: Latin America Market, By Country, 2022 to 2032
Table 13: Europe Market Value (US$ Mn), By Service Type, 2015 to 2021
Table 14: Europe Market Value (US$ Mn), By Service Type, 2022 to 2032
Table 15: Europe Market, By Country, 2015 to 2021
Table 16: Europe Market, By Country, 2022 to 2032
Table 17: Asia Pacific Market Value (US$ Mn), By Service Type, 2015 to 2021
Table 18: Asia Pacific Market Value (US$ Mn), By Service Type, 2022 to 2032
Table 19: Asia Pacific Market, By Country, 2015 to 2021
Table 20: Asia Pacific Market, By Country, 2022 to 2032
Table 21: MEA Market Value (US$ Mn), By Service Type, 2015 to 2021
Table 22: MEA Market Value (US$ Mn), By Service Type, 2022 to 2032
Table 23: MEA Market, By Country, 2015 to 2021
Table 24: MEA Market, By Country, 2022 to 2032
Table 25: Global Market Incremental $ Opportunity, By Service Type, 2015 to 2021
Table 26: Global Market Incremental $ Opportunity, By Region, 2022 to 2032
Table 27: North America Market Incremental $ Opportunity, By Service Type, 2015 to 2021
Table 28: North America Market Incremental $ Opportunity, By Country, 2022 to 2032
Table 29: Latin America Market Incremental $ Opportunity, By Service Type, 2015 to 2021
Table 30: Latin America Market Incremental $ Opportunity, By Country, 2022 to 2032
Table 31: Europe Market Incremental $ Opportunity, By Service Type, 2015 to 2021
Table 32: Europe Market Incremental $ Opportunity, By Country, 2022 to 2032
Table 33: Asia Pacific Market Incremental $ Opportunity, By Service Type, 2015 to 2021
Table 34: Asia Pacific Market Incremental $ Opportunity, By Country, 2022 to 2032
Table 35: MEA Market Incremental $ Opportunity, By Service Type, 2015 to 2021
Table 36: MEA Market Incremental $ Opportunity, By Country, 2022 to 2032
More Insights, Lesser Cost (-50% off)
Insights on import/export production,
pricing analysis, and more – Only @ Fact.MR
List Of Figures
Figure 1: Global Market Value (US$ Mn) and Year-on-Year Growth, 2015 to 2032
Figure 2: Global Market Absolute $ Historical Gain (2015 to 2021) and Opportunity (2022 to 2032), US$ Mn
Figure 3: Global Market Share, By Service Type, 2022 & 2032
Figure 4: Global Market Y-o-Y Growth Projections, By Service Type - 2022 to 2032
Figure 5: Global Market Attractiveness Index, By Service Type - 2022 to 2032
Figure 6: Global Market Share, By Region, 2022 & 2032
Figure 7: Global Market Y-o-Y Growth Projections, By Region - 2022 to 2032
Figure 8: Global Market Attractiveness Index, By Region - 2022 to 2032
Figure 9: North America Market Value (US$ Mn) and Year-on-Year Growth, 2015 to 2032
Figure 10: North America Market Absolute $ Opportunity Historical (2015 to 2021) and Forecast Period (2022 - 2032), US$ Mn
Figure 11: North America Market Share, By Service Type, 2022 & 2032
Figure 12: North America Market Y-o-Y Growth Projections, By Service Type - 2022 to 2032
Figure 13: North America Market Attractiveness Index, By Service Type - 2022 to 2032
Figure 14: North America Market Share, By Country, 2022 & 2032
Figure 15: North America Market Y-o-Y Growth Projections, By Country - 2022 to 2032
Figure 16: North America Market Attractiveness Index, By Country - 2022 to 2032
Figure 17: Latin America Market Value (US$ Mn) and Year-on-Year Growth, 2015 to 2032
Figure 18: Latin America Market Absolute $ Opportunity Historical (2015 to 2021) and Forecast Period (2022 - 2032), US$ Mn
Figure 19: Latin America Market Share, By Service Type, 2022 & 2032
Figure 20: Latin America Market Y-o-Y Growth Projections, By Service Type - 2022 to 2032
Figure 21: Latin America Market Attractiveness Index, By Service Type - 2022 to 2032
Figure 22: Latin America Market Share, By Country, 2022 & 2032
Figure 23: Latin America Market Y-o-Y Growth Projections, By Country - 2022 to 2032
Figure 24: Latin America Market Attractiveness Index, By Country - 2022 to 2032
Figure 25: Europe Market Value (US$ Mn) and Year-on-Year Growth, 2015 to 2032
Figure 26: Europe Market Absolute $ Opportunity Historical (2015 to 2021) and Forecast Period (2022 - 2032), US$ Mn
Figure 27: Europe Market Share, By Service Type, 2022 & 2032
Figure 28: Europe Market Y-o-Y Growth Projections, By Service Type - 2022 to 2032
Figure 29: Europe Market Attractiveness Index, By Service Type - 2022 to 2032
Figure 30: Europe Market Share, By Country, 2022 & 2032
Figure 31: Europe Market Y-o-Y Growth Projections, By Country - 2022 to 2032
Figure 32: Europe Market Attractiveness Index, By Country - 2022 to 2032
Figure 33: MEA Market Value (US$ Mn) and Year-on-Year Growth, 2015 to 2032
Figure 34: MEA Market Absolute $ Opportunity Historical (2015 to 2021) and Forecast Period (2022 - 2032), US$ Mn
Figure 35: MEA Market Share, By Service Type, 2022 & 2032
Figure 36: MEA Market Y-o-Y Growth Projections, By Service Type - 2022 to 2032
Figure 37: MEA Market Attractiveness Index, By Service Type - 2022 to 2032
Figure 38: MEA Market Share, By Country, 2022 & 2032
Figure 39: MEA Market Y-o-Y Growth Projections, By Country - 2022 to 2032
Figure 40: MEA Market Attractiveness Index, By Country - 2022 to 2032
Figure 41: Asia Pacific Market Value (US$ Mn) and Year-on-Year Growth, 2015 to 2032
Figure 42: Asia Pacific Market Absolute $ Opportunity Historical (2015 to 2021) and Forecast Period (2022 - 2032), US$ Mn
Figure 43: Asia Pacific Market Share, By Service Type, 2022 & 2032
Figure 44: Asia Pacific Market Y-o-Y Growth Projections, By Service Type - 2022 to 2032
Figure 45: Asia Pacific Market Attractiveness Index, By Service Type - 2022 to 2032
Figure 46: Asia Pacific Market Share, By Country, 2022 & 2032
Figure 47: Asia Pacific Market Y-o-Y Growth Projections, By Country - 2022 to 2032
Figure 48: Asia Pacific Market Attractiveness Index, By Country - 2022 to 2032
Figure 49: US Market Value (US$ Mn) and Forecast, 2022 to 2032
Figure 50: US Market Share, By Service Type, 2021
Figure 51: Canada Market Value (US$ Mn) and Forecast, 2022 to 2032
Figure 52: Canada Market Share, By Service Type, 2021
Figure 53: Brazil Market Value (US$ Mn) and Forecast, 2022 to 2032
Figure 54: Brazil Market Share, By Service Type, 2021
Figure 55: Mexico Market Value (US$ Mn) and Forecast, 2022 to 2032
Figure 56: Mexico Market Share, By Service Type, 2021
Figure 57: Germany Market Value (US$ Mn) and Forecast, 2022 to 2032
Figure 58: Germany Market Share, By Service Type, 2021
Figure 59: U.K. Market Value (US$ Mn) and Forecast, 2022 to 2032
Figure 60: U.K. Market Share, By Service Type, 2021
Figure 61: France Market Value (US$ Mn) and Forecast, 2022 to 2032
Figure 62: France Market Share, By Service Type, 2021
Figure 63: Italy Market Value (US$ Mn) and Forecast, 2022 to 2032
Figure 64: Italy Market Share, By Service Type, 2021
Figure 65: BENELUX Market Value (US$ Mn) and Forecast, 2022 to 2032
Figure 66: BENELUX Market Share, By Service Type, 2021
Figure 67: Nordic Countries Market Value (US$ Mn) and Forecast, 2022 to 2032
Figure 68: Nordic Countries Market Share, By Service Type, 2021
Figure 69: China Market Value (US$ Mn) and Forecast, 2022 to 2032
Figure 70: China Market Share, By Service Type, 2021
Figure 71: Japan Market Value (US$ Mn) and Forecast, 2022 to 2032
Figure 72: Japan Market Share, By Service Type, 2021
Figure 73: South Korea Market Value (US$ Mn) and Forecast, 2022 to 2032
Figure 74: South Korea Market Share, By Service Type, 2021
Figure 75: GCC Countries Market Value (US$ Mn) and Forecast, 2022 to 2032
Figure 76: GCC Countries Market Share, By Service Type, 2021
Figure 77: South Africa Market Value (US$ Mn) and Forecast, 2022 to 2032
Figure 78: South Africa Market Share, By Service Type, 2021
Figure 79: Turkey Market Value (US$ Mn) and Forecast, 2022 to 2032
Figure 80: Turkey Market Share, By Service Type, 2021
Know thy Competitors
Competitive landscape highlights only certain players
Complete list available upon request
- FAQs -
What is the projected growth rate for the global market for medical device complaint management?
Fact.MR expects the medical device complaint management market to grow at a 7% value CAGR from 2022 to 2032
What was the market value of medical device complaint management in 2021?
The global medical device complaint management market size was estimated at US$ 5 Bn in 2021
What is the anticipated market value for medical device complaint management in 2022?
As of 2022, demand for medical device complaint management is forecast to reach US$ 5.35 Bn
At what percentage did the medical device complaint management industry flourish from 2015-2021?
From 2015-2021, medical device complaint management demand surged at a CAGR of 6.7%
What are the growth prospects for medical device complaint management services in the U.S?
According to Fact.MR, the U.S is anticipated to accumulate 40% of the global medical device complaint management revenue
Which service type accounts for highest demand for medical device complaint management services?
Product surveillance and regulatory compliance services dominates the medical device complaint management market with a share of 55%.
How attractive are growth prospects in the Asia Pacific?
Fact.MR foresees the Asia Pacific market for medical device complaint management to flourish at a CAGR of 8.3%