Europe Medical Device Vigilance Software Market Report 2031 by Segments, Geography, Dynamics, Recent Developments, and Strategic Insights

Europe Medical Device Vigilance Software Market Size and Forecast (2021 - 2031), Regional Share, Trend, and Growth Opportunity Analysis Report Coverage: By Application (Diagnostic, Therapeutic, Surgical, Research, and Others), Deployment Mode (Cloud and On-Premise), End-Use Vertical [Clinical Research Organizations (CROs), Business Process Outsourcing (BPO), Original Equipment Manufacturers (OEMs), and Others], and Country

  • Report Code : TIPRE00039339
  • Category : Healthcare IT
  • Status : Published
  • No. of Pages : 101
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Europe Medical Device Vigilance Software Market Report by 2031

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The Europe medical device vigilance software market size is expected to reach US$ 280.23 million by 2031 from US$ 143.9 million in 2023. The market is estimated to record a CAGR of 8.7% during 2023–2031. Software as a medical device is likely to bring a new set of key trends in the market in the coming years.

Europe Medical Device Vigilance Software Market Analysis

Increasing regulatory compliance, rising medical technology, and increasing complexity of medical devices are driving the Europe medical device vigilance software market. The main goal of a medical device vigilance system is to improve the protection of the health and safety of patients, healthcare professionals, and the public by minimizing the probability of the recurrence of adverse incidents involving medical devices. This is achieved through a variety of mechanisms. Medical device vigilance entails gathering, assessing, understanding, and responding to new information about the risks associated with the use of medical devices. These risks are particularly adverse incidents, interactions with other substances or devices, contraindications, counterfeiting, malfunctions, and technical defects.

Europe Medical Device Vigilance Software Market Overview

The primary purpose of medical device vigilance software is to support post-market surveillance of medical devices, ensuring their continued safety and effectiveness throughout their lifecycle. Post-market surveillance is critical to ensure that there are no adverse events or other problems with a product. The risks with any unanticipated effects of long-term use are identified and addressed as soon as possible. The goal of post-market surveillance is to ensure that products remain safe and effective while also continuously monitoring their benefits and risks.

The features of medical device vigilance software include incident reports regarding malfunctions, gathering all pertinent data in accordance with medical device reporting, assigning special manufacturer report numbers, and fulfilling all paperwork and recordkeeping requirements; storing incident data, analyzing device attribution, and evaluating and investigating reports to quickly and easily retrieve the data; and creating numerous reports for submitting to various regulatory bodies across the region.

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Europe Medical Device Vigilance Software Market: Strategic Insights

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Europe Medical Device Vigilance Software Market Drivers and Opportunities

Increased Complexity of Medical Devices

Medical device software is a critical component of modern healthcare systems. Software solutions in the medical device market are required to manage user interfaces, patient data, regulations, and product complexity. Their adoption reduces the risks while developing medical devices and their software and helps accelerate software development and deployment. It oversees risk management in healthcare as well. As the medical device market expands, the challenge of balancing hardware, software, and regulation increases. Requirement management tools and medical device vigilance software are closely related in the healthcare industry with respect to medical device development and its lifecycle management. Thus, to handle the complexity of medical devices, the demand for medical device vigilance software is growing.

Advances in medical technologies have led to better diagnoses and treatments for earlier and more accurate diagnoses, more effective treatments, and ensuring the safety of the patients. Medical devices evolve rapidly with the integration of the digital system, modern and compact medical device designs, and reliance on the software system. This generates complexity in terms of monitoring, reporting, and ensuring the safety of the medical devices. In addition, adhering to stricter regulatory compliances encourages medical device manufacturers to adopt advanced software solutions that can handle the challenges due to the increased complexity of medical devices.

Digital Transformation in Healthcare

Europe's digital healthcare sector promotes the use of various digital technologies that improve healthcare facilities. The use of digital technologies for information and communication to manage illness, avoid health risks, and promote patient safety drives digitalization in the Europe healthcare sector. Authorities in Europe are constantly focused on providing enhanced services to the citizens. For this, they are continually engaged in investment activities. For example, the EU4Health Programme was adopted with a budget of over ~US$ 5.9 billion (EUR 5.3 billion) during the 2021–2027 period to build stronger, more resilient, and more accessible health systems. This investment fosters the healthcare system's digitalization and access to medicinal products, medical devices, and crisis-relevant products. With the majority of the new projects already underway since December 2023, the goal of the grants is to help EU countries implement the future European Health Data Space (EHDS). Such investment can promote the innovation, development, and adoption of medical device vigilance software that meets regulatory standards and improves patient safety. The adoption of vigilance software can enhance the resilience of health systems during health crises such as COVID-19. It can provide quicker reports and analyze data on medical device performance. During emergencies, it can support quicker decision-making and risk management. Thus, the digitalization of the healthcare system in Europe drives significant advancements across all aspects of healthcare, creating the potential for the industry to deliver better health outcomes more efficiently. This factor enables the adoption of solutions to minimize the risks to quality and fuels time to market and regulatory compliance, further fostering the demand for medical device vigilance software in Europe.

Europe Medical Device Vigilance Software Market Report Segmentation Analysis

Key segments that contributed to the derivation of the Europe medical device vigilance software market analysis are application, deployment mode, and end-use vertical.

  • Based on application, the market is divided into diagnostics, therapeutic, surgical, research, and others. The diagnostic segment held the largest Europe medical device vigilance software market share in 2023.
  • Based on deployment mode, the market is divided into cloud and on-premises. The cloud segment held a larger Europe medical device vigilance software market share in 2023.
  • Based on end-use vertical, the market is divided into CROs, BPO, OEMs, and others. The original equipment manufacturers (OEMs) segment held the largest Europe medical device vigilance software market share in 2023.

Europe Medical Device Vigilance Software Market Share Analysis by Geography

The Europe medical device vigilance software market is segmented into Germany, France, the UK, Russia, Spain, and the Rest of Europe. Germany dominated the market in 2023, followed by France and the UK.

Adverse incidents involving medical devices in the UK must be reported to the Medicines and Healthcare Products Regulatory Agency (MHRA). The MHRA oversees the UK medical device market. Once a medical device is placed on the UK market, the manufacturer is obligated to submit vigilance reports to the MHRA whenever certain types of incidents involving their device occur in the UK. The manufacturer must also take appropriate safety measures when necessary. The manufacturer must ensure that their device meets applicable safety and performance standards for the duration of its use. The medical device manufacturer, the UK Responsible Person, or the authorized representative based in Northern Ireland must report to the MHRA about incidents regarding the medical devices and post-market vigilance reports. Such mandates for the vigilance system report and surveillance drive the demand for medical device vigilance software for effective reporting and post-market surveillance.

Europe Medical Device Vigilance Software Market Report Scope

Europe Medical Device Vigilance Software Market News and Recent Developments

The Europe medical device vigilance software market is evaluated by gathering qualitative and quantitative data post primary and secondary research, which includes important corporate publications, association data, and databases. A few of the developments in the Europe medical device vigilance software market are listed below:

  • Oracle announced new capabilities in its AI-supported Oracle Argus and Safety One Intake solutions to help life science organizations meet evolving regulatory requirements and the rising volume of adverse event case workloads. With new enhancements designed to increase productivity, improve data privacy, and enhance reporting, users can more efficiently address dynamic, country-specific regulations and requirements and speed the reliability and transparency of safety case management from clinical trials through post-marketing surveillance. (Source: Oracle Corporation, Press Release, July 2024)
  • Ab Cube Company unveiled four new next-AI-generation vigilance applications in the AB Cube Galaxy. These new modules offer powerful enhancements to the core SafetyEasy Suite for fast, efficient, and scalable multivigilance operations. The company's new AI-driven module applies advanced Natural Language Processing (NLP) technology, allowing the customers to copy and paste the verbatim of their ICSR, which is then automatically converted into a case in the SafetyEasy Suite – reducing case intake effort by 70%. (Source: Ab Cube Company, Press Release, June 2024)

Europe Medical Device Vigilance Software Market Report Coverage and Deliverables

The "Europe Medical Device Vigilance Software Market Size and Forecast (2021–2031)" provides a detailed analysis of the market covering the areas mentioned below:

  • Europe medical device vigilance software market size and forecast at regional, and country levels for all the key market segments covered under the scope
  • Europe medical device vigilance software market trends, as well as market dynamics such as drivers, restraints, and key opportunities
  • Detailed PEST and SWOT analysis
  • Europe medical device vigilance software market analysis covering key market trends, regional framework, major players, regulations, and recent market developments
  • Industry landscape and competition analysis covering market concentration, heat map analysis, prominent players, and recent developments for the Europe medical device vigilance software market
  • Detailed company profiles
Report Coverage
Report Coverage

Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends

Segment Covered
Segment Covered

This text is related
to segments covered.

Regional Scope
Regional Scope

North America, Europe, Asia Pacific, Middle East & Africa, South & Central America

Country Scope
Country Scope

This text is related
to country scope.

Frequently Asked Questions


What is the estimated market size for the Europe medical device vigilance software market in 2023?

The Europe medical device vigilance software market was estimated to be US$ 143.90 million in 2023 and is expected to grow at a CAGR of 8.7% during the forecast period 2024 - 2031.

What are the driving factors impacting the Europe medical device vigilance software market?

Stringent regulatory requirements related to medical devices, rise in medical technology, and increased complexity of medical devices are the major factors that propel the Europe medical device vigilance software market.

What are the future trends of the Europe medical device vigilance software market?

Software as a Medical Device is anticipated to play a significant role in the Europe medical device vigilance software market in the coming years.

Which are the key players holding the major market share of the Europe medical device vigilance software market?

The key players holding majority shares in the Europe medical device vigilance software market are AB Cube S.A.S.; AssurX, Inc.; Oracle Corporation; Sparta Systems (Honeywell International Inc.); and Sarjen Systems Pvt. Ltd.

What will be the market size of the Europe medical device vigilance software market by 2031?

The Europe medical device vigilance software market is expected to reach US$ 280.23 million by 2031.

What is the incremental growth of the Europe medical device vigilance software market during the forecast period?

The incremental growth expected to be recorded for the Europe medical device vigilance software market during the forecast period is US$ 136.33 million.

1. Introduction

1.1 The Insight Partners Research Report Guidance

1.2 Market Segmentation

2. Executive Summary

2.1 Key Insights

2.2 Market Attractiveness

3. Research Methodology

3.1 Secondary Research

3.2 Primary Research

3.2.1 Hypothesis formulation:

3.2.2 Macro-economic factor analysis:

3.2.3 Developing base number:

3.2.4 Data Triangulation:

3.2.5 Country level data:

4. Europe Medical Device Vigilance Software Market Landscape

4.1 Overview

4.2 PEST Analysis

4.3 Ecosystem Analysis

4.3.1 List of Vendors in the Value Chain

5. Europe Medical Device Vigilance Software Market – Key Market Dynamics

5.1 Europe Medical Device Vigilance Software Market – Key Market Dynamics

5.2 Market Drivers

5.2.1 Stringent Regulatory Requirements Related to Medical Devices

5.2.2 Rise in Medical Technology

5.2.3 Increased Complexity of Medical Devices

5.3 Market Restraints

5.3.1 Data Privacy and Cybersecurity Threats

5.4 Market Opportunities

5.4.1 Digital Transformation in Healthcare

5.4.2 Growing Medical Devices Market

5.5 Future Trends

5.5.1 Software as a Medical Device

5.6 Impact of Drivers and Restraints:

6. Europe Medical Device Vigilance Software Market Analysis

6.1 Europe Medical Device Vigilance Software Market Revenue (US$ Million), 2021–2031

6.2 Europe Medical Device Vigilance Software Market Forecast and Analysis

7. Europe Medical Device Vigilance Software Market Analysis – by Application

7.1 Diagnostic

7.1.1 Overview

7.1.2 Diagnostic: Europe Medical Device Vigilance Software Market – Revenue and Forecast to 2031 (US$ Million)

7.2 Therapeutic

7.2.1 Overview

7.2.2 Therapeutic: Europe Medical Device Vigilance Software Market – Revenue and Forecast to 2031 (US$ Million)

7.3 Surgical

7.3.1 Overview

7.3.2 Surgical: Europe Medical Device Vigilance Software Market – Revenue and Forecast to 2031 (US$ Million)

7.4 Research

7.4.1 Overview

7.4.2 Research: Europe Medical Device Vigilance Software Market – Revenue and Forecast to 2031 (US$ Million)

7.5 Others

7.5.1 Overview

7.5.2 Others: Europe Medical Device Vigilance Software Market – Revenue and Forecast to 2031 (US$ Million)

8. Europe Medical Device Vigilance Software Market Analysis – by Deployment Mode

8.1 Cloud

8.1.1 Overview

8.1.2 Cloud: Europe Medical Device Vigilance Software Market – Revenue and Forecast to 2031 (US$ Million)

8.2 On-Premise

8.2.1 Overview

8.2.2 On-Premise: Europe Medical Device Vigilance Software Market – Revenue and Forecast to 2031 (US$ Million)

9. Europe Medical Device Vigilance Software Market Analysis – by End Use Vertical

9.1 Clinical Research Organizations (CROs)

9.1.1 Overview

9.1.2 Clinical Research Organizations (CROs): Europe Medical Device Vigilance Software Market – Revenue and Forecast to 2031 (US$ Million)

9.2 Business Process Outsourcing (BPO)

9.2.1 Overview

9.2.2 Business Process Outsourcing (BPO): Europe Medical Device Vigilance Software Market – Revenue and Forecast to 2031 (US$ Million)

9.3 Original Equipment Manufacturers (OEMs)

9.3.1 Overview

9.3.2 Original Equipment Manufacturers (OEMs): Europe Medical Device Vigilance Software Market – Revenue and Forecast to 2031 (US$ Million)

9.4 Others

9.4.1 Overview

9.4.2 Others: Europe Medical Device Vigilance Software Market – Revenue and Forecast to 2031 (US$ Million)

10. Europe Medical Device Vigilance Software Market – Country Analysis

10.1 Europe

10.1.1 Europe Medical Device Vigilance Software Market Breakdown by Countries

10.1.2 Europe Medical Device Vigilance Software Market Revenue and Forecast and Analysis – by Country

10.1.2.1 Europe Medical Device Vigilance Software Market Revenue and Forecast and Analysis – by Country

10.1.2.2 Germany: Europe Medical Device Vigilance Software Market – Revenue and Forecast to 2031 (US$ Million)

10.1.2.2.1 Germany: Europe Medical Device Vigilance Software Market Breakdown by Application

10.1.2.2.2 Germany: Europe Medical Device Vigilance Software Market Breakdown by Deployment Mode

10.1.2.2.3 Germany: Europe Medical Device Vigilance Software Market Breakdown by End Use Vertical

10.1.2.3 France: Europe Medical Device Vigilance Software Market – Revenue and Forecast to 2031 (US$ Million)

10.1.2.3.1 France: Europe Medical Device Vigilance Software Market Breakdown by Application

10.1.2.3.2 France: Europe Medical Device Vigilance Software Market Breakdown by Deployment Mode

10.1.2.3.3 France: Europe Medical Device Vigilance Software Market Breakdown by End Use Vertical

10.1.2.4 United Kingdom: Europe Medical Device Vigilance Software Market – Revenue and Forecast to 2031 (US$ Million)

10.1.2.4.1 United Kingdom: Europe Medical Device Vigilance Software Market Breakdown by Application

10.1.2.4.2 United Kingdom: Europe Medical Device Vigilance Software Market Breakdown by Deployment Mode

10.1.2.4.3 United Kingdom: Europe Medical Device Vigilance Software Market Breakdown by End Use Vertical

10.1.2.5 Spain: Europe Medical Device Vigilance Software Market – Revenue and Forecast to 2031 (US$ Million)

10.1.2.5.1 Spain: Europe Medical Device Vigilance Software Market Breakdown by Application

10.1.2.5.2 Spain: Europe Medical Device Vigilance Software Market Breakdown by Deployment Mode

10.1.2.5.3 Spain: Europe Medical Device Vigilance Software Market Breakdown by End Use Vertical

10.1.2.6 Russia: Europe Medical Device Vigilance Software Market – Revenue and Forecast to 2031 (US$ Million)

10.1.2.6.1 Russia: Europe Medical Device Vigilance Software Market Breakdown by Application

10.1.2.6.2 Russia: Europe Medical Device Vigilance Software Market Breakdown by Deployment Mode

10.1.2.6.3 Russia: Europe Medical Device Vigilance Software Market Breakdown by End Use Vertical

10.1.2.7 Rest of Europe: Europe Medical Device Vigilance Software Market – Revenue and Forecast to 2031 (US$ Million)

10.1.2.7.1 Rest of Europe: Europe Medical Device Vigilance Software Market Breakdown by Application

10.1.2.7.2 Rest of Europe: Europe Medical Device Vigilance Software Market Breakdown by Deployment Mode

10.1.2.7.3 Rest of Europe: Europe Medical Device Vigilance Software Market Breakdown by End Use Vertical

11. Competitive Landscape

11.1 Heat Map Analysis by Key Players

11.2 Company Positioning & Concentration

12. Industry Landscape

12.1 Overview

12.2 Market Initiative

12.2 New Product Development

13. Company Profiles

13.1 Oracle Corp

13.1.1 Key Facts

13.1.2 Business Description

13.1.3 Products and Services

13.1.4 Financial Overview

13.1.5 SWOT Analysis

13.1.6 Key Developments

13.2 AB Cube S.A.S.

13.2.1 Key Facts

13.2.2 Business Description

13.2.3 Products and Services

13.2.4 Financial Overview

13.2.5 SWOT Analysis

13.2.6 Key Developments

13.3 Sarjen Systems Pvt. Ltd

13.3.1 Key Facts

13.3.2 Business Description

13.3.3 Products and Services

13.3.4 Financial Overview

13.3.5 SWOT Analysis

13.3.6 Key Developments

13.4 AssurX, Inc.

13.4.1 Key Facts

13.4.2 Business Description

13.4.3 Products and Services

13.4.4 Financial Overview

13.4.5 SWOT Analysis

13.4.6 Key Developments

13.5 UL Solutions Inc

13.5.1 Key Facts

13.5.2 Business Description

13.5.3 Products and Services

13.5.4 Financial Overview

13.5.5 SWOT Analysis

13.5.6 Key Developments

13.6 Honeywell International Inc

13.6.1 Key Facts

13.6.2 Business Description

13.6.3 Products and Services

13.6.4 Financial Overview

13.6.5 SWOT Analysis

13.6.6 Key Developments

13.7 PTC Inc

13.7.1 Key Facts

13.7.2 Business Description

13.7.3 Products and Services

13.7.4 Financial Overview

13.7.5 SWOT Analysis

13.7.6 Key Developments

13.8 Intel Corp

13.8.1 Key Facts

13.8.2 Business Description

13.8.3 Products and Services

13.8.4 Financial Overview

13.8.5 SWOT Analysis

13.8.6 Key Developments

13.9 Max Application

13.9.1 Key Facts

13.9.2 Business Description

13.9.3 Products and Services

13.9.4 Financial Overview

13.9.5 SWOT Analysis

13.9.6 Key Developments

13.10 Xybion Digital Inc.

13.10.1 Key Facts

13.10.2 Business Description

13.10.3 Products and Services

13.10.4 Financial Overview

13.10.5 SWOT Analysis

13.10.6 Key Developments

14. Appendix

14.1 Appendix

14.2 About The Insight Partners

List of Tables

Table 1. Europe Medical Device Vigilance Software Market Segmentation

Table 2. List of Vendors

Table 3. Europe Medical Device Vigilance Software Market – Revenue and Forecast to 2031 (US$ Million)

Table 4. Europe Medical Device Vigilance Software Market – Revenue and Forecast to 2031 (US$ Million) – by Application

Table 5. Europe Medical Device Vigilance Software Market – Revenue and Forecast to 2031 (US$ Million) – by Deployment Mode

Table 6. Europe Medical Device Vigilance Software Market – Revenue and Forecast to 2031 (US$ Million) – by End Use Vertical

Table 7. Europe Medical Device Vigilance Software Market – Revenue and Forecast to 2031 (US$ Million) – by Country

Table 8. Germany: Europe Medical Device Vigilance Software Market – Revenue and Forecast to 2031 (US$ Million) – by Application

Table 9. Germany: Europe Medical Device Vigilance Software Market – Revenue and Forecast to 2031 (US$ Million) – by Deployment Mode

Table 10. Germany: Europe Medical Device Vigilance Software Market – Revenue and Forecast to 2031 (US$ Million) – by End Use Vertical

Table 11. France: Europe Medical Device Vigilance Software Market – Revenue and Forecast to 2031 (US$ Million) – by Application

Table 12. France: Europe Medical Device Vigilance Software Market – Revenue and Forecast to 2031 (US$ Million) – by Deployment Mode

Table 13. France: Europe Medical Device Vigilance Software Market – Revenue and Forecast to 2031 (US$ Million) – by End Use Vertical

Table 14. United Kingdom: Europe Medical Device Vigilance Software Market – Revenue and Forecast to 2031 (US$ Million) – by Application

Table 15. United Kingdom: Europe Medical Device Vigilance Software Market – Revenue and Forecast to 2031 (US$ Million) – by Deployment Mode

Table 16. United Kingdom: Europe Medical Device Vigilance Software Market – Revenue and Forecast to 2031 (US$ Million) – by End Use Vertical

Table 17. Spain: Europe Medical Device Vigilance Software Market – Revenue and Forecast to 2031 (US$ Million) – by Application

Table 18. Spain: Europe Medical Device Vigilance Software Market – Revenue and Forecast to 2031 (US$ Million) – by Deployment Mode

Table 19. Spain: Europe Medical Device Vigilance Software Market – Revenue and Forecast to 2031 (US$ Million) – by End Use Vertical

Table 20. Russia: Europe Medical Device Vigilance Software Market – Revenue and Forecast to 2031 (US$ Million) – by Application

Table 21. Russia: Europe Medical Device Vigilance Software Market – Revenue and Forecast to 2031 (US$ Million) – by Deployment Mode

Table 22. Russia: Europe Medical Device Vigilance Software Market – Revenue and Forecast to 2031 (US$ Million) – by End Use Vertical

Table 23. Rest of Europe: Europe Medical Device Vigilance Software Market – Revenue and Forecast to 2031 (US$ Million) – by Application

Table 24. Rest of Europe: Europe Medical Device Vigilance Software Market – Revenue and Forecast to 2031 (US$ Million) – by Deployment Mode

Table 25. Rest of Europe: Europe Medical Device Vigilance Software Market – Revenue and Forecast to 2031 (US$ Million) – by End Use Vertical

List of Figures

Figure 1. Europe Medical Device Vigilance Software Market Segmentation, by Country

Figure 2. PEST Analysis

Figure 3. Ecosystem Analysis

Figure 4. Impact Analysis of Drivers and Restraints

Figure 5. Europe Medical Device Vigilance Software Market Revenue (US$ Million), 2021–2031

Figure 6. Europe Medical Device Vigilance Software Market Share (%) – by Application, 2023 and 2031

Figure 7. Diagnostic: Europe Medical Device Vigilance Software Market – Revenue and Forecast to 2031 (US$ Million)

Figure 8. Therapeutic: Europe Medical Device Vigilance Software Market – Revenue and Forecast to 2031 (US$ Million)

Figure 9. Surgical: Europe Medical Device Vigilance Software Market – Revenue and Forecast to 2031 (US$ Million)

Figure 10. Research: Europe Medical Device Vigilance Software Market – Revenue and Forecast to 2031 (US$ Million)

Figure 11. Others: Europe Medical Device Vigilance Software Market – Revenue and Forecast to 2031 (US$ Million)

Figure 12. Europe Medical Device Vigilance Software Market Share (%) – by Deployment Mode, 2023 and 2031

Figure 13. Cloud: Europe Medical Device Vigilance Software Market – Revenue and Forecast to 2031 (US$ Million)

Figure 14. On-Premise: Europe Medical Device Vigilance Software Market – Revenue and Forecast to 2031 (US$ Million)

Figure 15. Europe Medical Device Vigilance Software Market Share (%) – by End Use Vertical, 2023 and 2031

Figure 16. Clinical Research Organizations (CROs): Europe Medical Device Vigilance Software Market – Revenue and Forecast to 2031 (US$ Million)

Figure 17. Business Process Outsourcing (BPO): Europe Medical Device Vigilance Software Market – Revenue and Forecast to 2031 (US$ Million)

Figure 18. Original Equipment Manufacturers (OEMs): Europe Medical Device Vigilance Software Market – Revenue and Forecast to 2031 (US$ Million)

Figure 19. Others: Europe Medical Device Vigilance Software Market – Revenue and Forecast to 2031 (US$ Million)

Figure 20. Europe Medical Device Vigilance Software Market Breakdown by Key Countries, 2023 and 2031 (%)

Figure 21. Germany: Europe Medical Device Vigilance Software Market – Revenue and Forecast to 2031 (US$ Million)

Figure 22. France: Europe Medical Device Vigilance Software Market – Revenue and Forecast to 2031 (US$ Million)

Figure 23. United Kingdom: Europe Medical Device Vigilance Software Market – Revenue and Forecast to 2031 (US$ Million)

Figure 24. Spain: Europe Medical Device Vigilance Software Market – Revenue and Forecast to 2031 (US$ Million)

Figure 25. Russia: Europe Medical Device Vigilance Software Market – Revenue and Forecast to 2031 (US$ Million)

Figure 26. Rest of Europe: Europe Medical Device Vigilance Software Market – Revenue and Forecast to 2031 (US$ Million)

Figure 27. Heat Map Analysis by Key Players

Figure 28. Company Positioning & Concentration

The List of Companies - Europe Medical Device Vigilance Software Market

  1. Oracle Corp
  2. AB Cube S.A.S.
  3. Sarjen Systems Pvt. Ltd
  4. AssurX, Inc.
  5. UL Solutions Inc
  6. Honeywell International Inc
  7. PTC Inc
  8. Intel Corp
  9. Max Application
  10. Xybion Digital Inc.

The Insight Partners performs research in 4 major stages: Data Collection & Secondary Research, Primary Research, Data Analysis and Data Triangulation & Final Review.

  1. Data Collection and Secondary Research:

As a market research and consulting firm operating from a decade, we have published many reports and advised several clients across the globe. First step for any study will start with an assessment of currently available data and insights from existing reports. Further, historical and current market information is collected from Investor Presentations, Annual Reports, SEC Filings, etc., and other information related to company’s performance and market positioning are gathered from Paid Databases (Factiva, Hoovers, and Reuters) and various other publications available in public domain.

Several associations trade associates, technical forums, institutes, societies and organizations are accessed to gain technical as well as market related insights through their publications such as research papers, blogs and press releases related to the studies are referred to get cues about the market. Further, white papers, journals, magazines, and other news articles published in the last 3 years are scrutinized and analyzed to understand the current market trends.

  1. Primary Research:

The primarily interview analysis comprise of data obtained from industry participants interview and answers to survey questions gathered by in-house primary team.

For primary research, interviews are conducted with industry experts/CEOs/Marketing Managers/Sales Managers/VPs/Subject Matter Experts from both demand and supply side to get a 360-degree view of the market. The primary team conducts several interviews based on the complexity of the markets to understand the various market trends and dynamics which makes research more credible and precise.

A typical research interview fulfils the following functions:

  • Provides first-hand information on the market size, market trends, growth trends, competitive landscape, and outlook
  • Validates and strengthens in-house secondary research findings
  • Develops the analysis team’s expertise and market understanding

Primary research involves email interactions and telephone interviews for each market, category, segment, and sub-segment across geographies. The participants who typically take part in such a process include, but are not limited to:

  • Industry participants: VPs, business development managers, market intelligence managers and national sales managers
  • Outside experts: Valuation experts, research analysts and key opinion leaders specializing in the electronics and semiconductor industry.

Below is the breakup of our primary respondents by company, designation, and region:

Research Methodology

Once we receive the confirmation from primary research sources or primary respondents, we finalize the base year market estimation and forecast the data as per the macroeconomic and microeconomic factors assessed during data collection.

  1. Data Analysis:

Once data is validated through both secondary as well as primary respondents, we finalize the market estimations by hypothesis formulation and factor analysis at regional and country level.

  • 3.1 Macro-Economic Factor Analysis:

We analyse macroeconomic indicators such the gross domestic product (GDP), increase in the demand for goods and services across industries, technological advancement, regional economic growth, governmental policies, the influence of COVID-19, PEST analysis, and other aspects. This analysis aids in setting benchmarks for various nations/regions and approximating market splits. Additionally, the general trend of the aforementioned components aid in determining the market's development possibilities.

  • 3.2 Country Level Data:

Various factors that are especially aligned to the country are taken into account to determine the market size for a certain area and country, including the presence of vendors, such as headquarters and offices, the country's GDP, demand patterns, and industry growth. To comprehend the market dynamics for the nation, a number of growth variables, inhibitors, application areas, and current market trends are researched. The aforementioned elements aid in determining the country's overall market's growth potential.

  • 3.3 Company Profile:

The “Table of Contents” is formulated by listing and analyzing more than 25 - 30 companies operating in the market ecosystem across geographies. However, we profile only 10 companies as a standard practice in our syndicate reports. These 10 companies comprise leading, emerging, and regional players. Nonetheless, our analysis is not restricted to the 10 listed companies, we also analyze other companies present in the market to develop a holistic view and understand the prevailing trends. The “Company Profiles” section in the report covers key facts, business description, products & services, financial information, SWOT analysis, and key developments. The financial information presented is extracted from the annual reports and official documents of the publicly listed companies. Upon collecting the information for the sections of respective companies, we verify them via various primary sources and then compile the data in respective company profiles. The company level information helps us in deriving the base number as well as in forecasting the market size.

  • 3.4 Developing Base Number:

Aggregation of sales statistics (2020-2022) and macro-economic factor, and other secondary and primary research insights are utilized to arrive at base number and related market shares for 2022. The data gaps are identified in this step and relevant market data is analyzed, collected from paid primary interviews or databases. On finalizing the base year market size, forecasts are developed on the basis of macro-economic, industry and market growth factors and company level analysis.

  1. Data Triangulation and Final Review:

The market findings and base year market size calculations are validated from supply as well as demand side. Demand side validations are based on macro-economic factor analysis and benchmarks for respective regions and countries. In case of supply side validations, revenues of major companies are estimated (in case not available) based on industry benchmark, approximate number of employees, product portfolio, and primary interviews revenues are gathered. Further revenue from target product/service segment is assessed to avoid overshooting of market statistics. In case of heavy deviations between supply and demand side values, all thes steps are repeated to achieve synchronization.

We follow an iterative model, wherein we share our research findings with Subject Matter Experts (SME’s) and Key Opinion Leaders (KOLs) until consensus view of the market is not formulated – this model negates any drastic deviation in the opinions of experts. Only validated and universally acceptable research findings are quoted in our reports.

We have important check points that we use to validate our research findings – which we call – data triangulation, where we validate the information, we generate from secondary sources with primary interviews and then we re-validate with our internal data bases and Subject matter experts. This comprehensive model enables us to deliver high quality, reliable data in shortest possible time.

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