GVR Report cover Medical Device Complaint Management Market Size, Share & Trends Report

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 - 2030

  • Report ID: GVR-2-68038-783-4
  • Number of Report Pages: 111
  • Format: PDF, Horizon Databook
  • Historical Range: 2016 - 2020
  • Forecast Period: 2022 - 2030 
  • Industry: Healthcare

Report Overview

The global medical device complaint management market size was valued at USD 6.5 billion in 2021 and is expected to expand at a compound annual growth rate (CAGR) of 8.5% from 2022 to 2030. 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. 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.

U.S. medical device complaint management market size, by service type, 2020 - 2030 (USD Billion)

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 enhances 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. For example, key players are developing innovative mobile application solutions to enhance customer complaints management. For instance, Intellect offers an integrated mobile application platform allowing customers to register complaints, escalate ticks, and generate queries. The Intellect mobile application is easily available on the App Store and the Google Play Store and can be downloaded as an Intellect application or a custom branded mobile application.

COVID-19 medical device complaint management market impact: 16.8% increase in revenue from 2019 to 2020

Pandemic Impact

Post COVID Outlook

The medical device complaint management market decreased by 16.8% from 2019 to 2020.

The market is estimated to witness a y-o-y growth of 7.0% to 8.5% in the next 5 years.

The ongoing Covid-19 pandemic significantly impacted the normal functioning of healthcare systems and disrupted manufacturing cycles and supply and demand chains and led to numerous product defects and failures.

The fluctuating demand for medical devices across markets will lead to tight inventory management, slower reordering, and delayed product launches.

The U.S. 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 coronavirus.

Manufacturers need to follow reporting requirements as mentioned in the EUA letter for authorized devices and report any adverse events or product failures through an electronic medical device reporting (eMDR) system established by the U.S. FDA.


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 MedWatcher. The MedWatcher 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.

Service Type Insights

The product surveillance and regulatory compliance segment dominated the market in 2021 and accounted for a revenue share of over 55.0%. 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.

Regional Insights

North America dominated the market for medical device complaint management in 2021 and accounted for a revenue share of over 40.0% 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.

Global medical device complaint management market share, by region, 2021 (%)

Asia Pacific is anticipated to grow lucratively over the forthcoming years. The presence of renowned multinational companies such as Wipro and Tata Consultancy Services (TCS) spearheading the complaint management market in the Asia Pacific is expected to drive the market in Asia Pacific. The European market is anticipated to expand at a significant CAGR 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.

Key Companies & Market Share Insights

Key players are constantly devising innovative product development strategies and revising their collaborations and mergers & acquisitions strategies to gain a competitive edge in the market and expand their business footprint. The majority of the medical device companies operating in the industry are thriving for efficient complaint management systems in order to attain all-around regulatory compliance. Thus, the manufacturers are focused on providing these companies with upgraded complaint management systems through innovation and offering inputs for improvements in designs, thereby resulting in a competitive edge on the account of improved product quality and minimum complaints. 

Some prominent players in the global medical device complaint management market include:


  • Wipro

  • Tata Consultancy Services (TCS)

  • MasterControl

  • Biovia

  • Freyr

  • Sparta Systems

  • SAS

  • AssurX

  • Parexel International Corporation

Medical Device Complaint Management Market Report Scope

Report Attribute


Market size value in 2022

USD 7.0 billion

Revenue forecast in 2030

USD 13.4 billion

Growth Rate

CAGR of 8.5% from 2022 to 2030

Base year for estimation


Historical data

2016 - 2020

Forecast period

2022 - 2030

Quantitative units

Revenue in USD million/billion and CAGR from 2022 to 2030

Report coverage

Revenue, company ranking, competitive landscape, growth factors, and trends

Segments covered

Service type, region

Regional scope

North America; Europe; Asia Pacific; Latin America; MEA

Country scope

U.S.; Canada; Germany; U.K.; Spain; Italy; France; Japan; China; India; Australia; Brazil; Mexico; South Africa; Saudi Arabia

Key companies profiled

Tata Consulting Services (TCS); IQVIA; Biovia; Wipro; Sparta Systems; AssurX; Freyr; SAS; Parexel International Corporation; MasterControl

Customization scope

Free report customization (equivalent up to 8 analysts working days) with purchase. Addition or alteration to country, regional & segment scope.

Pricing and purchase options

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Segments Covered in the Report

This report forecasts revenue growth at the global, regional, and country levels and provides an analysis of the latest industry trends and opportunities in each of the sub-segments from 2016 to 2030. For the purpose of this study, Grand View Research, Inc. has segmented the global medical device complaint management market report based on service type and region:

  • Service Type Outlook (Revenue, USD Million, 2016 - 2030)

    • Complaints Log / Intake

      • Receive Complaints

      • Classify the Issue

      • Record Issue

    • Product Surveillance & Regulatory Compliance

      • Reportable/Non-reportable

      • Medical Device Vigilance/Medical Device Reporting

      • Field Action

    • Returned/ Non-returned Product Analysis

      • Complaint Investigation

      • Root Cause Analysis, Testing

      • Corrective/Preventive Action

    • Resolve & Closure

      • Complaint Summary

      • Customer Letter Creation

  • Regional Outlook (Revenue, USD Million, 2016 - 2030)

    • North America

      • U.S.

      • Canada

    • Europe

      • Germany

      • U.K.

      • Spain

      • Italy

      • France

    • Asia Pacific

      • Japan

      • China

      • India

      • Australia

    • Latin America

      • Brazil

      • Mexico

    • MEA

      • South Africa

      • Saudi Arabia

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