The global Medical Device Complaint Management market size is expected to be worth around US$ 11.2 billion by 2030, according to a new report by Vision Research Reports.
The global Medical Device Complaint Management market size was valued at US$ 6.37 billion in 2020 and is anticipated to grow at a CAGR of 8.6% during forecast period 2021 to 2030.
Increasing use of software to support the entire complaint management process is propelling the growth. The transition from paper-based to digital system for tracking complaints is boosting growth of the market. Incidents are recorded and the data automatically drives the investigation and resolution workflow. Companies experience more complete documentation along with the reduction in the turnaround time. The complaints management solution provides advanced analytics and reporting tools for augmented management oversight. The software also streamlines the submissions with standard reporting for the EU, FDA, Japan, Health Canada, and Australia.
For instance, the U.S. FDA encourages consumers, patients, and healthcare professionals to give voluntary reports of important adverse events, and/or product issues to MedWatch, FDA’s Safety Information and Adverse Event Reporting Program or by means of the mobile app known as MedWatcher. The app radically simplifies and accelerates the process of reporting by providing users with a four-step form submitted electronically to the FDA.
The product surveillance and regulatory compliance services segment accounted for the largest market share in 2019. This growth can be attributed to the fact that the regulatory agencies and users of medical devices are becoming less tolerant of the failure of the medical devices as it results in the serious injury, death, or potential harm to the users. Also, the regulatory agencies are placing greater emphasis on product surveillance to track product performance and manage compliance.
In product surveillance segment, medical device vigilance/medical device reporting is anticipated to showcase the fastest growth through the forecast period. The growth can be attributed to the fact that the U.S. FDA makes it mandatory for the firms that have received complaints of serious injuries or deaths related to the medical devices, and device malfunction to notify the incident. Any non-compliance with the regulatory requirement may result in a hefty fine for each day.
The complaint log/intake segment is anticipated to showcase a robust growth over the forecast period. As it is the initial stage of managing the complaints and are a gateway mechanism for corrective action/preventive action and post-market activities. Complaint files are also linked to a Medical Device Reporting (MDR) event file because a complaint must be assessed to determine if it is a reportable adverse event. Furthermore, it is mandatory for the medical device manufacturers to record and track customer complaints as per the quality system regulation (QSR) defined in 21 CFR Part 820.
North America led the market in 2019 and is projected to remain dominant through the forecast period. Stringent regulatory requirements regarding complaint handling and management is driving the regional growth. For instance, in the U.S., the regulation of MDR comprises of mandatory requirements for user facilities, manufacturers, and importers to report certain device-related adverse events and problems related to products to the FDA.
Europe is projected to expand at the fastest CAGR throughout the forecast period. The Europe market is strictly regulated and it is mandatory for the medical device manufacturers to report incidents and Field Safety Corrective Actions (FSCA) to the European competent authorities. Manufacturers that fail to report the incidents could face severe consequences.
Asia Pacific is also anticipated to register robust growth over the forecast period. This is due to the fact that major MNCs such as Tata Consultancy Services (TCS) and Wipro have their operating offices in India, driving the regional growth.
Tata Consulting Services (TCS); IQVIA; Biovia; Wipro; Sparta Systems; AssurX; Freyr; SAS; Parexel International Corporation; MasterControl
Classify the Issue
Product Surveillance & Regulatory Compliance
Medical Device Vigilance/Medical Device Reporting
Returned/Non-Returned Product Analysis
Root Cause Analysis, Testing
Resolve & Closure
Customer Letter Creation
Middle East & Africa
The Medical Device Complaint Management market research report covers definition, classification, product classification, product application, development trend, product technology, competitive landscape, industrial chain structure, industry overview, national policy and planning analysis of the industry, the latest dynamic analysis, etc., and also includes major. The study includes drivers and restraints of the global market. It covers the impact of these drivers and restraints on the demand during the forecast period. The report also highlights opportunities in the market at the global level.
The report provides size (in terms of volume and value) of Medical Device Complaint Management market for the base year 2020 and the forecast between 2021 and 2030. Market numbers have been estimated based on form and application. Market size and forecast for each application segment have been provided for the global and regional market.
This report focuses on the global Medical Device Complaint Management market status, future forecast, growth opportunity, key market and key players. The study objectives are to present the Medical Device Complaint Management market development in United States, Europe and China.
It is pertinent to consider that in a volatile global economy, we haven’t just conducted Medical Device Complaint Management market forecasts in terms of CAGR, but also studied the market based on key parameters, including Year-on-Year (Y-o-Y) growth, to comprehend the certainty of the market and to find and present the lucrative opportunities in market.
In terms of production side, this report researches the Medical Device Complaint Management capacity, production, value, ex-factory price, growth rate, market share for major manufacturers, regions (or countries) and type.
In terms of consumption side, this report focuses on the consumption of Medical Device Complaint Management by regions (countries) and application.
Buyers of the report will have access to verified market figures, including global market size in terms of revenue and volume. As part of production analysis, the authors of the report have provided reliable estimations and calculations for global revenue and volume by Type segment of the global Medical Device Complaint Management market. These figures have been provided in terms of both revenue and volume for the period 2017 to 2030. Additionally, the report provides accurate figures for production by region in terms of revenue as well as volume for the same period. The report also includes production capacity statistics for the same period.
With regard to production bases and technologies, the research in this report covers the production time, base distribution, technical parameters, research and development trends, technology sources, and sources of raw materials of major Medical Device Complaint Management market companies.
Regarding the analysis of the industry chain, the research of this report covers the raw materials and equipment of Medical Device Complaint Management market upstream, downstream customers, marketing channels, industry development trends and investment strategy recommendations. The more specific analysis also includes the main application areas of market and consumption, major regions and Consumption, major Chinese producers, distributors, raw material suppliers, equipment providers and their contact information, industry chain relationship analysis.
The research in this report also includes product parameters, production process, cost structure, and data information classified by region, technology and application. Finally, the paper model new project SWOT analysis and investment feasibility study of the case model.
Overall, this is an in-depth research report specifically for the Medical Device Complaint Management industry. The research center uses an objective and fair way to conduct an in-depth analysis of the development trend of the industry, providing support and evidence for customer competition analysis, development planning, and investment decision-making. In the course of operation, the project has received support and assistance from technicians and marketing personnel in various links of the industry chain.
The Medical Device Complaint Management market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the companies’ focus related to Medical Device Complaint Management market.
Prominent players in the market are predicted to face tough competition from the new entrants. However, some of the key players are targeting to acquire the startup companies in order to maintain their dominance in the global market. For a detailed analysis of key companies, their strengths, weaknesses, threats, and opportunities are measured in the report by using industry-standard tools such as the SWOT analysis. Regional coverage of key companies is covered in the report to measure their dominance. Key manufacturers of Medical Device Complaint Management market are focusing on introducing new products to meet the needs of the patrons. The feasibility of new products is also measured by using industry-standard tools.
Key companies are increasing their investments in research and development activities for the discovery of new products. There has also been a rise in the government funding for the introduction of new Medical Device Complaint Management market. These factors have benefited the growth of the global market for Medical Device Complaint Management. Going forward, key companies are predicted to benefit from the new product launches and the adoption of technological advancements. Technical advancements have benefited many industries and the global industry is not an exception.
New product launches and the expansion of already existing business are predicted to benefit the key players in maintaining their dominance in the global market for Medical Device Complaint Management. The global market is segmented on the basis of region, application, en-users and product type. Based on region, the market is divided into North America, Europe, Asia-Pacific, Latin America and Middle East and Africa (MEA).
In this study, the years considered to estimate the market size of Medical Device Complaint Management are as follows:
Reasons to Purchase this Report:
- Market segmentation analysis including qualitative and quantitative research incorporating the impact of economic and policy aspects
- Regional and country level analysis integrating the demand and supply forces that are influencing the growth of the market.
- Market value USD Million and volume Units Million data for each segment and sub-segment
- Competitive landscape involving the market share of major players, along with the new projects and strategies adopted by players in the past five years
- Comprehensive company profiles covering the product offerings, key financial information, recent developments, SWOT analysis, and strategies employed by the major market players
In-depth interviews and discussions were conducted with several key market participants and opinion leaders to compile the research report.
This research study involved the extensive usage of both primary and secondary data sources. The research process involved the study of various factors affecting the industry, including the government policy, market environment, competitive landscape, historical data, present trends in the market, technological innovation, upcoming technologies and the technical progress in related industry, and market risks, opportunities, market barriers and challenges. The following illustrative figure shows the market research methodology applied in this report.
Market Size Estimation
Top-down and bottom-up approaches are used to estimate and validate the global market size for company, regional division, product type and application (end users).
The market estimations in this report are based on the selling price (excluding any discounts provided by the manufacturer, distributor, wholesaler or traders). Market share analysis, assigned to each of the segments and regions are achieved through product utilization rate and average selling price.
Major manufacturers & their revenues, percentage splits, market shares, growth rates and breakdowns of the product markets are determined through secondary sources and verified through the primary sources.
All possible factors that influence the markets included in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data. The market size for top-level markets and sub-segments is normalized, and the effect of inflation, economic downturns, and regulatory & policy changes or others factors are accounted for in the market forecast. This data is combined and added with detailed inputs and analysis from Vision Research Reports and presented in this report.
Market Breakdown and Data Triangulation
After complete market engineering with calculations for market statistics; market size estimations; market forecasting; market breakdown; and data triangulation. Extensive primary research was conducted to gather information and verify and validate the critical numbers arrived at. In the complete market engineering process, both top-down and bottom-up approaches were extensively used, along with several data triangulation methods, to perform market estimation and market forecasting for the overall market segments and sub-segments listed in this report.
Secondary Sources occupies approximately 25% of data sources, such as press releases, annual reports, Non-Profit organizations, industry associations, governmental agencies and customs data, and so on. This research study includes secondary sources; directories; databases such as Bloomberg Business, Wind Info, Hoovers, Factiva (Dow Jones & Company), TRADING ECONOMICS, and avention; Investing News Network; statista; Federal Reserve Economic Data; annual reports; investor presentations; and SEC filings of companies.
In the primary research process, various sources from both the supply and demand sides were interviewed to obtain qualitative and quantitative information for this report. The primary sources from the supply side include product manufacturers (and their competitors), opinion leaders, industry experts, research institutions, distributors, dealer and traders, as well as the raw materials suppliers and producers, etc.
The primary sources from the demand side include industry experts such as business leaders, marketing and sales directors, technology and innovation directors, supply chain executive, end users (product buyers), and related key executives from various key companies and organizations operating in the global market.
The study objectives of this report are:
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