Top Factor Driving Medical Devices Vigilance Market Growth in 2025: Surging Medical Device Recalls Fuel Growth In The Medical Device Vigilance Market

How Big Is the Medical Devices Vigilance Market Expected to Be, and What Will Its Growth Rate Be?
The medical devices vigilance market will rise from $90.26 billion in 2024 to $97.94 billion in 2025, at a CAGR of 8.5%. This growth is driven by increasing awareness about medical device vigilance, growing recognition of the benefits among physicians and patients, and rising pressure on manufacturers, along with government initiatives.

The medical devices vigilance market is expected to grow to $137.61 billion by 2029 at a CAGR of 8.9%, driven by the increasing number of device recalls and post-market surveillance. Trends include technological advancements, international safety regulations, remote patient monitoring, and 3D printing for personalized devices.

What Are the Primary Growth Drivers for the Medical Devices Vigilance Market?
The growing frequency of medical recalls is anticipated to accelerate the expansion of the medical device vigilance market. Medical recalls involve actions taken by regulatory bodies, manufacturers, or distributors to withdraw or rectify medical products that present a health risk or fail to meet regulatory standards. Medical device vigilance encompasses ongoing monitoring of devices in the market to detect adverse events, malfunctions, or safety concerns, which, once identified, are reported to regulatory authorities. This can lead to further investigations and, if necessary, product recalls. For example, in December 2022, the Food and Drug Administration (FDA), a US-based federal agency, reported a rise in medical device recalls, with 442 recalls in 2022, an increase of nearly 10% from 331 in 2021. As a result, the growing number of medical recalls is propelling the growth of the medical device vigilance market.

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Who Are the Dominant Companies Influencing Medical Devices Vigilance Market Trends?
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 Key Developments Are Influencing the Medical Devices Vigilance Market?
Leading companies in the medical device vigilance market are creating innovative products like quality management software to enhance customer satisfaction. Quality management software helps companies document processes to achieve quality policies and objectives. For instance, in December 2022, Greenlight Guru, a US-based software provider for medical device companies, launched QMS software to streamline clinical testing and bring safer products to market faster. The software is pre-validated for FDA and ISO standards and helps companies comply with evolving regulations while offering training and certifications for career advancement in product development and quality assurance.

What Are the Different Segmentations 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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Which Region Is at the Forefront of the Medical Devices Vigilance Market?
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.

What Is Covered In The Medical Devices Vigilance Global Market Report?

- Market Size Analysis: Analyze the Medical Devices Vigilance Market size by key regions, countries, product types, and applications.
- Market Segmentation Analysis: Identify various subsegments within the Medical Devices Vigilance Market for effective categorization.
- Key Player Focus: Focus on key players to define their market value, share, and competitive landscape.
- Growth Trends Analysis: Examine individual growth trends and prospects in the Market.
- Market Contribution: Evaluate contributions of different segments to the overall Medical Devices Vigilance Market growth.
- Growth Drivers: Detail key factors influencing market growth, including opportunities and drivers.
- Industry Challenges: Analyze challenges and risks affecting the Medical Devices Vigilance Market.
- Competitive Developments: Analyze competitive developments, such as expansions, agreements, and new product launches in the market.

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