Surging Medical Device Recalls Fuel Growth In The Medical Device Vigilance Market Driving Market Acceleration in the Medical Devices Vigilance Industry, 2025

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How Large Will the Medical Devices Vigilance Market Size By 2025?
The market for medical devices vigilance has experienced robust growth in the past few years. It is predicted that it will escalate from a worth of $90.26 billion in 2024 to $97.94 billion in 2025, demonstrating a compound annual growth rate (CAGR) of 8.5%. Factors such as enhanced awareness about medical device vigilance, increased understanding of its benefits among physicians and patients, intensified pressure on manufacturers of medical devices, an increase in government initiatives, and rising usage of medical devices, contribute to the growth experienced during the historical period.

How Big Is the Medical Devices Vigilance Market Size Expected to Grow by 2029?
The market for medical devices vigilance is predicted to experience significant expansion in the coming years. The projection is that it will escalate to $137.61 billion by 2029, with a compound annual growth rate (CAGR) of 8.9%. This projected growth in the forecast period is due to several factors including the rising implementation of recall systems for medical devices, an increase in post-market surveillance initiatives for these devices, a growing number of reported adverse events, spiralling demand for therapeutic and surgical procedures, and the escalating complexity surrounding patient safety regulations. Key trends expected during this forecast period include advancements in technology, the framework of the International Medical Device Regulators Forum (IMDRF), improved cross-border safety information exchange, advancements in remote patient monitoring devices, 3D printing, and personalized devices.

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Which Key Market Drivers Powering Medical Devices Vigilance Market Expansion and Growth?
The surge in medical product recalls is anticipated to boost the expansion of the medical device vigilance market in the coming years. A medical recall is initiated by regulatory bodies, manufacturers, or distributors to withdraw or rectify medical products that are either dangerous to public health or fail to meet the required regulatory standards. Medical device vigilance is the consistent scrutiny of medical devices on the market in order to detect any adverse events, operational failures, or safety issues, which upon detection, are reported to regulatory authorities and may subsequently trigger an inquiry and potentially a product recall if found necessary. For instance, the US-based federal agency, the Food and Drug Administration (FDA), noticed an escalation in medical device recalls in December 2022, documenting 442 recalls compared to 331 in 2021, marking almost a 10% surge since 2021. Hence, the rising count of medical recalls is fueling the growth of the medical device vigilance market.

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Which Fast-Growing Trends Are Poised to Disrupt the Medical Devices Vigilance Market?
Key firms in the medical device vigilance market, such as Greenlight Guru, are inventing fresh products like quality management software (QMS) to enhance client satisfaction. The QMS is a standardized system designed for recording procedures, processes, and responsibilities to achieve quality standards and goals. For example, in December 2022, Greenlight Guru, a company hailing from the US that specializes in offering systems and software to the medical device industry, unveiled a QMS software. This software is aimed at assisting medical device companies in updating their systems, reducing clinical testing time, and hastening the launch of safer products in the market. The software, compliant with FDA and ISO optimal practices, is pre-verified which aims to promote companies' compliance with the constantly shifting standards. Greenlight Guru also presents certifications and training programs in order to propel careers in product development, quality control, and regulatory assurance forward.

What Are the Emerging Segments in the Medical Devices Vigilance Market?
The medical devices vigilance market 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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Who Are the Global Leaders 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 are the Top Profitable Regional Markets for the Medical Devices Vigilance Industry?
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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