The global medical device complaint management market size is expected to reach USD 10.2 billion by 2026, according to a new report by Grand View Research, Inc. It is anticipated to register a CAGR of 7.6% during the forecast period. 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.
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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.
Regulators are gradually concentrating on handling customer complaints, product safety, and device vigilance. This is not only true in developed countries, but also in emerging economies such as India. The Indian government introduced medical devices regulation program, Materiovigilance Programme of India (MvPI) with focus on safety data collection, synchronization of international laws, regulations, and standards encourages medical device organizations to evaluate their existing procedures of product development and post-marketing surveillance.
Further key findings from the study suggest:
- Product surveillance and regulatory compliance emerged as the largest segment owing to greater emphasis put on product surveillance by regulatory agencies
- North America held the largest market share in 2017 owing to stern regulatory requirements and heavy monetary fines in this region. All the device manufacturers, importers, and distributors are required to comply with the complaint and record requirement
- Some of the key players operating in the medical device complaint management market include IQVIA, Wipro, Tata Consulting Services, SAS, Sparta Systems, Parexel International Corporation, Biovia, AssurX, MasterControl, and Freyr.
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Grand View Research has segmented the global medical device complaint management market based on service and region:
Medical Device Complaint Management Service Outlook (Revenue, USD Million, 2014 – 2026)
- 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
Medical Device Complaint Management Regional Outlook (USD Million, 2014 – 2026)
- North America
- Asia Pacific
- Latin America
- Middle East & Africa
- South Africa
- Saudi Arabia
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About Grand View Research
Grand View Research provides syndicated as well as customized research reports and consulting services on 46 industries across 25 major countries worldwide. This U.S.-based market research and consulting company is registered in California and headquartered in San Francisco. Comprising over 425 analysts and consultants, the company adds 1200+ market research reports to its extensive database each year. Supported by an interactive market intelligence platform, the team at Grand View Research guides Fortune 500 companies and prominent academic institutes in comprehending the global and regional business environment and carefully identifying future opportunities.
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