Overview


According to FutureWise analysis the market for Medical Devices Vigilance in 2023 is US$ 79.63 billion, and is expected to reach US$ 150.92 billion by 2031 at a CAGR of 8.32%.

Medical devices span a wide range of products, from diagnostic medical devices used to detect diseases and anomalies to therapeutic medical devices used to cut tissue, cover wounds, or close open clogged arteries, to extremely complicated and computerised medical equipment. Because of their great diversity and crucial necessity for therapeutic treatment and patient care, it is becoming increasingly important to regulate the manufacturing, operating, and distribution processes to assure their quality, safety, and efficient operation. The collection, evaluation, reporting, quality check, and recognition of the condition of medical devices as a result of their use is known as medical device vigilance or materiovigilance. Medical device vigilance attempts to protect patients, healthcare facilities that use medical devices, and others by preventing or eliminating errors that cause dangerous occurrences and bad effects. Medical device vigilance keeps track of technical faults and potential side effects linked with medical devices. With the passage of the Modernization Act 1970 in the United States, the FDA began post-market surveillance of medical devices. The fundamental goal of medical device vigilance is to promote patient health and safety by lowering the number of incidents connected to medical device use. Adverse responses to medical equipment can occur and have serious implications. The medical device vigilance market is being driven by a number of factors including an increase in the number of medical device recalls due to technical defects, an increase in the number of post-market surveillance programmes, an increase in the incidences of adverse events related to faulty medical devices, an increase in the number of hospitals using medical devices, and the adoption of medical device vigilance software.

FutureWise Market Research has instantiated a report that provides an intricate analysis of Medical Devices Vigilance Market trends that shall affect the overall market growth. Furthermore, it includes detailed information on the graph of profitability, SWOT analysis, market share and regional proliferation of this business. Moreover, the report offers insights on the current stature of prominent market players in the competitive landscape analysis of this market.

According to the research study conducted by FutureWise research analysts, the Medical Devices Vigilance Market is anticipated to attain substantial growth by the end of the forecast period. The report explains that this business is predicted to register a noteworthy growth rate over the forecast period. This report provides crucial information pertaining to the total valuation that is presently held by this industry and it also lists the segmentation of the market along with the growth opportunities present across this business vertical.

  • AB-Cube
  • AssurX
  • Oracle Corporation
  • Sarjen Systems
  • Sparta Systems
  • Xybion Corporation
  • ZEINCRO
  • Omnify Software
  • INTEL
  • Numerix

(Note: The list of the major players will be updated with the latest market scenario and trends)

By Mode of Development

  • Cloud-based
  • On-premises

By Application

  • Diagnostic Application
  • Therapeutic Application
  • Surgical Application
  • Research Application
  • Other Applications

By End User

  • Medical Devices Manufacturers
  • Clinical Research Organizations (CROs)
  • Business Processes Outsourcing (BPOs)

By Region

  • North America
  • Europe
  • Asia-Pacific
  • Latin America
  • Middle East and Africa
  • Tier 1 players- established companies in the market with a major market share
  • Tier 2 players
  • Emerging players which are growing rapidly
  • New Entrants
  • Growth prospects
  • SWOT analysis
  • Key trends
  • Key data-points affecting market growth
  • To provide with an exhaustive analysis on the Medical Devices Vigilance Market By Mode of Development, By Application, By End User and By Region.
  • To cater comprehensive information on factors impacting market growth (drivers, restraints, opportunities, and industry-specific restraints)
  • To evaluate and forecast micro-markets and the overall market
  • To predict the market size, in key regions— North America, Europe, Asia Pacific, Latin America and Middle East and Africa.
  • To record and evaluate competitive landscape mapping- product launches, technological advancements, mergers and expansions
  • We have a flexible delivery model and you can suggest changes in the scope/table of content as per your requirement
  • The customization Mobility Care offered are free of charge with purchase of any license of the report
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Table of Contents


  • 1.   Market Introduction
    •   1. Objectives of the Study
        2. Market Definition
        3. Market Scope
         3.1. Years Considered for the Study
         3.2. Market Covered
        4. Currency
        5. Limitations
        6. Stakeholders
  • 2.   Research Methodology
    •   1. Research Data
         1.1. Secondary Data
          1.1.1. Key Data from Secondary Sources
         1.2. Primary Data
          1.2.1. Key Data from Primary Sources
        2. Market Size Estimation
        3. Market Breakdown and Data Triangulation
        4. Assumptions for the Study
  • 3.   Executive Summary
    •   1. Market Outlook
        2. Segment Outlook
        3. Competitive Insights
  • 4.   Medical Devices Vigilance Market Variables, Trends and Scope
    •   1. Market Lineage Outlook
        2. Penetration and Growth Prospect Mapping
        3. Industry Value Chain Analysis
        4. Cost Analysis Breakdown
        5. Technology Overview
        6. Regulatory Framework
         6.1. Reimbursement Framework
         6.2. Standards and Compliances

  • 5.   Market Overview
    •   1. Market Dynamics
         1.1. Market Driver Analysis
          1.1.1. Increasing focus of Medical Devices Vigilance Market Companies on Brand Protection
          1.1.2. Untapped Opportunities in Emerging Regions
         1.2. Market Restraint Analysis
          1.2.1. High Cost Associated with Implementation of Predictive Analysis
         1.3. Industry Challenges
          1.3.1. Presence of Ambiguous Regulatory Framework
  • 6.   Medical Devices Vigilance Market Analysis Tools
    •   1. Industry Analysis - Porter’s
         1.1. Supplier Power
         1.2. Buyer Power
         1.3. Substitution Threat
         1.4. Threat from New Entrants
         1.5. Competitive Rivalry
        2. Pestel Analysis
         2.1. Political Landscape
         2.2. Environmental Landscape
         2.3. Social Landscape
         2.4. Technology Landscape
         2.5. Legal Landscape
        3. Major Deals And Strategic Alliances Analysis
         3.1. Joint Ventures
         3.2. Mergers and Acquisitions
         3.3. Licensing and Partnership
         3.4. Technology Collaborations
         3.5. Strategic Divestments
        4. Market Entry Strategies
        5. Case Studies
  • 7.   Medical Devices Vigilance Market, By Mode of Development Historical Analysis and Forecast 2023-2031 (USD Million)
    •   1. Cloud-based
        2. On-premises

  • 8.   Medical Devices Vigilance Market, By Application Historical Analysis and Forecast 2023-2031 (USD Million)
    •   1. Diagnostic Application
        2. Therapeutic Application
        3. Surgical Application
        4. Research Application
        5. Other Applications

  • 9.   Medical Devices Vigilance Market, By End User Historical Analysis and Forecast 2023-2031 (USD Million)
    •   1. Medical Devices Manufacturers
        2. Clinical Research Organizations (CROs)
        3. Business Processes Outsourcing (BPOs)

  • 10.   North America Medical Devices Vigilance Market Analysis 2017-2022 and Forecast 2023-2031 (USD Million)
    •   1. Introduction
        2. Historical Market Size (USD Million) Analysis By Country, 2017-2022
         2.1. U.S.A
         2.2. Canada
         2.3. Mexico
        3. Market Size (USD Million) Forecast for North America 2023-2031

  • 11.   Latin America Medical Devices Vigilance Market Analysis 2017-2022 and Forecast 2023-2031 (USD Million)
    •   1. Introduction
        2. Historical Market Size (USD Million) Analysis By Country, 2017-2022
         2.1. Brazil
         2.2. Venezuela
         2.3. Argentina
         2.4. Rest of Latin America
        3. Market Size (USD Million) Forecast for Latin America 2023-2031

  • 12.   Europe Medical Devices Vigilance Market Analysis 2017-2022 and Forecast 2023-2031 (USD Million)
    •   1. Introduction
        2. Historical Market Size (USD Million) Analysis By Country, 2017-2022
         2.1. Germany
         2.2. U.K
         2.3. France
         2.4. Italy
         2.5. Spain
         2.6. Russia
         2.7. Poland
         2.8. Rest of Europe
        3. Market Size (USD Million) Forecast for Europe 2023-2031

  • 13.   Asia Pacific Medical Devices Vigilance Market Analysis 2017-2022 and Forecast 2023-2031 (USD Million)
    •   1. Introduction
        2. Historical Market Size (USD Million) Analysis By Country, 2017-2022
         2.1. Japan
         2.2. China
         2.3. India
         2.4. Australia and New Zealand
         2.5. ASEAN
         2.6. Rest of Asia Pacific
        3. Market Size (USD Million) Forecast for Asia Pacific 2023-2031

  • 14.   Middle East and Africa Market Analysis 2017-2022 and Forecast 2023-2031 (USD Million)
    •   1. Introduction
        2. Historical Market Size (USD Million) Analysis By Country, 2017-2022
         2.1. GCC
         2.2. Israel
         2.3. South Africa
         2.4. Rest of MEA
        3. Market Size (USD Million) Forecast for MEA 2023-2031

  • 15.   Market Share Analysis and Competitive Landscape
    •   1. Global Landscape - Key Players, Revenue and Presence
        2. Global Share Analysis - Key Players (Tier 1, Tier 2, Tier 3)
        3. Global Emerging Companies
        4. North America - Market Share Analysis and Key Regional Players
        5. Europe - Market Share Analysis and Key Regional Players
        6. Asia Pacific - Market Share Analysis and Key Regional Players
        7. Global Key Player - Growth Matrix
  • 16.   Company Profiles (Competition Dashboard, Competitors Deep Dive, Products Offered and Financial Layouts)
    •   1. AB-Cube
         1.1. Company Overview
         1.2. Product Portfolio
         1.3. SWOT Analysis
         1.4. Financial Overview
         1.5. Strategic Overview
        2. AssurX
         2.1. Company Overview
         2.2. Product Portfolio
         2.3. SWOT Analysis
         2.4. Financial Overview
         2.5. Strategic Overview
        3. Oracle Corporation
         3.1. Company Overview
         3.2. Product Portfolio
         3.3. SWOT Analysis
         3.4. Financial Overview
         3.5. Strategic Overview
        4. Sarjen Systems
         4.1. Company Overview
         4.2. Product Portfolio
         4.3. SWOT Analysis
         4.4. Financial Overview
         4.5. Strategic Overview
        5. Sparta Systems
         5.1. Company Overview
         5.2. Product Portfolio
         5.3. SWOT Analysis
         5.4. Financial Overview
         5.5. Strategic Overview
        6. Xybion Corporation
         6.1. Company Overview
         6.2. Product Portfolio
         6.3. SWOT Analysis
         6.4. Financial Overview
         6.5. Strategic Overview
        7. ZEINCRO
         7.1. Company Overview
         7.2. Product Portfolio
         7.3. SWOT Analysis
         7.4. Financial Overview
         7.5. Strategic Overview
        8. Omnify Software
         8.1. Company Overview
         8.2. Product Portfolio
         8.3. SWOT Analysis
         8.4. Financial Overview
         8.5. Strategic Overview
        9. INTEL
         9.1. Company Overview
         9.2. Product Portfolio
         9.3. SWOT Analysis
         9.4. Financial Overview
         9.5. Strategic Overview
        10. Numerix
         10.1. Company Overview
         10.2. Product Portfolio
         10.3. SWOT Analysis
         10.4. Financial Overview
         10.5. Strategic Overview

  • 17.   Pre and Post COVID-19 Impact
    •   1. Positive influence on the healthcare industry
        2. The financial disruption of the manufacturing sector
        3. Impact of COVID-19 on emerging companies
        4. Significant mandates in the regulations initiated by healthcare administrations
        5. The overall economic slowdown of the developing and developed nations
  • 18.   FutureWise SME Key Takeaway Points for Client
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