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 - 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

Global Medical Device Complaint Management Market Outlook (2022-2032)

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 2022-2032 and reach a value of US$ 10.52 Bn.

Report Attributes


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)


Key Companies Profiled

  • Parexel
  • SAS Institute
  • Wipro Limited
  • Tata Consultancy Services
  • Sparta Systems Inc.
  • Freyr Solutions
  • AssurX
  • MasterControl Inc.

Demand Analysis of Medical Device Complaint Management from 2015-2021 Vs Future Outlook 2022-2032

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.

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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.

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 2021-2027. 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.

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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.

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

Know thy Competitors

Competitive landscape highlights only certain players
Complete list available upon request

Medical Device Complaint Management Market Report Scope

Report Attributes


Forecast Period


Historical Data Available for


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
  • 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

- FAQs -

Fact.MR expects the medical device complaint management market to grow at a 7% value CAGR from 2022 to 2032

The global medical device complaint management market size was estimated at US$ 5 Bn in 2021

As of 2022, demand for medical device complaint management is forecast to reach US$ 5.35 Bn

From 2015-2021, medical device complaint management demand surged at a CAGR of 6.7%

According to Fact.MR, the U.S is anticipated to accumulate 40% of the global medical device complaint management revenue

Product surveillance and regulatory compliance services dominates the medical device complaint management market with a share of 55%.

Fact.MR foresees the Asia Pacific market for medical device complaint management to flourish at a CAGR of 8.3%

Medical Device Complaint Management Market

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