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Medical Devices Vigilance Market on Track for Strong Growth, Estimated to Grow at 8.8% CAGR Through 2029

11-18-2025 07:27 AM CET | Health & Medicine

Press release from: The Business Research Company

Medical Devices Vigilance

Medical Devices Vigilance

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What Is the Expected CAGR for the Medical Devices Vigilance Market Through 2025?
The realm of medical devices vigilance has experienced significant expansion lately, projected to increase its market value from $90.26 billion in 2024 to $97.66 billion the following year, indicating a steady compound annual growth rate (CAGR) of 8.2%. This upswing in growth over the past period stems from several factors, including escalating recognition of the importance of medical device vigilance, increased understanding among both medical practitioners and the general public about the advantages offered by such vigilance systems, mounting obligations placed upon companies that manufacture medical devices, a greater volume of governmental programs supporting this area, and a general increase in the deployment of medical technologies.

What's the Projected Size of the Global Medical Devices Vigilance Market by 2029?
Anticipating a robust expansion over the coming years, the medical devices vigilance market is projected to achieve a valuation of $136.86 billion by 2029, expanding at a compound annual growth rate (CAGR) of 8.8%. This upward trajectory during the projection timeframe stems from several key factors: the proliferation of recall systems for medical apparatus, a rise in post-market surveillance initiatives concerning medical devices, a growing volume of reported adverse incidents, escalating requirements for therapeutic interventions and surgical operations, and the mounting complexity surrounding regulations focused on patient safety. Key developments poised to shape this market throughout the forecast include ongoing technological progress, the adoption of the International Medical Device Regulators Forum (IMDRF) framework which facilitates enhanced international sharing of safety data, the growing use of remote patient monitoring equipment, and innovations related to 3D printing and customized devices.

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Top Growth Drivers in the Medical Devices Vigilance Industry: What's Accelerating the Market?
The upward trend in medical product recalls is anticipated to fuel the expansion of the medical device vigilance sector moving ahead. These recalls signify actions implemented by regulatory bodies, producers, or suppliers to withdraw or rectify medical items that present hazards to general well-being or fail to adhere to established regulations. Concurrently, medical device vigilance involves the ongoing surveillance of devices available commercially to detect any unfavorable occurrences, operational failures, or safety issues; once detected, these events are officially reported to governing authorities, which may initiate further inquiry and, if deemed necessary, result in a product recall. As an illustration, during December of 2022, the US federal agency known as the Food and Drug Administration (FDA) noted an escalation in recalls pertaining to medical devices, recording 442 such instances throughout that year, a marked increase from the 331 recorded in 2021, representing nearly a 10 percent jump compared to the previous year's figures. Consequently, the rising frequency of these product recalls is serving as a catalyst for the growth trajectory within the medical device vigilance market.

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What Trends Will Shape the Medical Devices Vigilance Market Through 2029 and Beyond?
Leading firms within the medical device vigilance sector are focused on creating novel offerings, such as software for quality management, with the goal of enhancing client contentment. Quality management software, often abbreviated as QMS, represents a structured framework that records the necessary operations, protocols, and accountabilities required to attain predetermined quality aims and mandates. As an illustration, in the twelfth month of 2022, Greenlight Guru, a United States corporation supplying various systems and software solutions to medical device manufacturers, introduced its QMS platform; this new software was specifically engineered to assist these enterprises in contemporaryizing their workflows, expediting the duration of clinical trials, and introducing safer items to the marketplace at an accelerated pace. Greenlight Guru's system boasts pre-validation according to the optimal methods established by the FDA and ISO, thereby assisting organizations in adhering to constantly evolving regulatory benchmarks. Furthermore, this organization extends educational programs and official certifications intended to foster professional growth in the domains of product creation, quality control, and regulatory compliance verification.

What Are the Main Segments in the Medical Devices Vigilance Market?
The medical devices vigilancemarket covered in this report is segmented -

1) By Delivery Mode: On-Demand; On-Premise
2) By Application: Therapeutics; Diagnostics; Surgical; Research; Other Applications
3) By End-User: Original Equipment Manufacturers (OEMs); Clinical Research Organizations (CROs); Business Process Outsourcing (BPO) Firms

Subsegments:
1) By On-Demand: Cloud-Based Solutions; Subscription Services; Remote Monitoring And Reporting
2) By On-Premise: In-House Software Solutions; Local Server Deployments; Customized System Implementations

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Which Top Companies are Driving Growth in the Medical Devices Vigilance Market?
Major companies operating in the medical devices vigilance market are Johnson & Johnson, Intel Corporation, Oracle Corporation, Medtronic, Siemens Healthineers, RELX Group plc, MasterControl Inc., Laerdal Medical, Numerix, Smithers, Omnify Software Inc., Freyr, Sparta Systems, MDI Consultants Inc., Greenlight Guru, Jama Software, Sarjen Systems Pvt. Ltd, Arena Solutions Inc., Xybion Corporation, ZEINCRO Group, Extedo Gmbh, AssurX Inc., AB-Cube, Panacea Pharma Projects Limited, Qvigilance, General Electric (GE) Healthcare, Philips Healthcare, Baxter International, Stryker Corporation, Boston Scientific

Which Regions Will Dominate the Medical Devices Vigilance Market Through 2029?
North America was the largest region in the medical devices vigilance market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in the medical devices vigilance market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa.

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