1. Preface
1.1. Market Definition and Scope
1.2. Market Segmentation
1.3. Key Research Objectives
1.4. Research Highlights
2. Assumptions and Research Methodology
3. Executive Summary: Global Medical Device & IVD Regulatory Affairs Outsourcing Market
4. Market Overview
4.1. Introduction & Overview
4.2. Product Overview
4.3. Market Dynamics
4.3.1. Drivers
4.3.2. Restraints
4.3.3. Opportunities
4.4. Global Medical Device & IVD Regulatory Affairs Outsourcing Market Analysis and Forecast, 2018–2030
5. Market Outlook
5.1. COVID-19 Pandemics Impact on Industry
5.2. Technology/Product Roadmap
5.3. Market Channel Development Trends
5.4. Key Potential Customers
6. Global Medical Device & IVD Regulatory Affairs Outsourcing Market Analysis and Forecast, by Service
6.1. Introduction & Definition
6.2. Global Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Service, 2018–2030
6.2.1. Regulatory Writing & Submissions
6.2.2. Regulatory Registration Service
6.2.3. Regulatory Consulting
6.2.4. Others
6.3. Global Medical Device & IVD Regulatory Affairs Outsourcing Market Attractiveness Analysis, by Service
7. Global Medical Device & IVD Regulatory Affairs Outsourcing Market Analysis and Forecast, by Software
7.1. Introduction & Definition
7.2. Global Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Software, 2018–2030
7.2.1. Cloud-based software
7.2.2. On-premises software
7.3. Global Medical Device & IVD Regulatory Affairs Outsourcing Market Attractiveness Analysis, by Software
8. Global Medical Device & IVD Regulatory Affairs Outsourcing Market Analysis and Forecast, by Region
8.1. Key Findings
8.2. Global Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Region
8.2.1. North America
8.2.2. Europe
8.2.3. Asia Pacific
8.2.4. Latin America
8.2.5. Middle East & Africa
8.3. Global Medical Device & IVD Regulatory Affairs Outsourcing Market Attractiveness Analysis, by Region
9. North America Medical Device & IVD Regulatory Affairs Outsourcing Market Analysis and Forecast
9.1. Introduction
9.2. North America Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Service, 2018–2030
9.2.1. Regulatory Writing & Submissions
9.2.2. Regulatory Registration Service
9.2.3. Regulatory Consulting
9.2.4. Others
9.3. North America Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Software, 2018–2030
9.3.1. Cloud-based software
9.3.2. On-premises software
9.4. North America Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Country, 2018–2030
9.4.1. U.S.
9.4.2. Canada
9.5. North America Medical Device & IVD Regulatory Affairs Outsourcing Market Attractiveness Analysis
9.5.1. By Service
9.5.2. By Software
9.5.3. By Country
10. Europe Medical Device & IVD Regulatory Affairs Outsourcing Market Analysis and Forecast
10.1. Introduction
10.2. Europe Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Service, 2018–2030
10.2.1. Regulatory Writing & Submissions
10.2.2. Regulatory Registration Service
10.2.3. Regulatory Consulting
10.2.4. Others
10.3. Europe Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Software, 2018–2030
10.3.1. Cloud-based software
10.3.2. On-premises software
10.4. Europe Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Country/Sub-region, 2018–2030
10.4.1. Germany
10.4.2. U.K.
10.4.3. France
10.4.4. Spain
10.4.5. Italy
10.4.6. Rest of Europe
10.5. Europe Medical Device & IVD Regulatory Affairs Outsourcing Market Attractiveness Analysis
10.5.1. By Service
10.5.2. By Software
10.5.3. By Country/Sub-region
11. Asia Pacific Medical Device & IVD Regulatory Affairs Outsourcing Market Analysis and Forecast
11.1. Introduction
11.2. Asia Pacific Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Service, 2018–2030
11.2.1. Regulatory Writing & Submissions
11.2.2. Regulatory Registration Service
11.2.3. Regulatory Consulting
11.2.4. Others
11.3. Asia Pacific Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Software, 2018–2030
11.3.1. Cloud-based software
11.3.2. On-premises software
11.4. Asia Pacific Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Country/Sub-region, 2018–2030
11.4.1. China
11.4.2. Japan
11.4.3. India
11.4.4. Australia & New Zealand
11.4.5. Rest of Asia Pacific
11.5. Asia Pacific Medical Device & IVD Regulatory Affairs Outsourcing Market Attractiveness Analysis
11.5.1. By Service
11.5.2. By Software
11.5.3. By Country/Sub-region
12. Latin America Medical Device & IVD Regulatory Affairs Outsourcing Market Analysis and Forecast
12.1. Introduction
12.2. Latin America Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Service, 2018–2030
12.2.1. Regulatory Writing & Submissions
12.2.2. Regulatory Registration Service
12.2.3. Regulatory Consulting
12.2.4. Others
12.3. Latin America Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Software, 2018–2030
12.3.1. Cloud-based software
12.3.2. On-premises software
12.4. Latin America Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Country/Sub-region, 2018–2030
12.4.1. Brazil
12.4.2. Mexico
12.4.3. Rest of Latin America
12.5. Latin America Medical Device & IVD Regulatory Affairs Outsourcing Market Attractiveness Analysis
12.5.1. By Service
12.5.2. By Software
12.5.3. By Country/Sub-region
13. Middle East & Africa Medical Device & IVD Regulatory Affairs Outsourcing Market Analysis and Forecast
13.1. Introduction
13.2. Middle East & Africa Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Service, 2018–2030
13.2.1. Regulatory Writing & Submissions
13.2.2. Regulatory Registration Service
13.2.3. Regulatory Consulting
13.2.4. Others
13.3. Middle East & Africa Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Software, 2018–2030
13.3.1. Cloud-based software
13.3.2. On-premises software
13.4. Middle East & Africa Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Country/Sub-region, 2018–2030
13.4.1. GCC Countries
13.4.2. South Africa
13.4.3. Rest of Middle East & Africa
13.5. Middle East & Africa Medical Device & IVD Regulatory Affairs Outsourcing Market Attractiveness Analysis
13.5.1. By Service
13.5.2. By Software
13.5.3. By Country/Sub-region
14. Competition Landscape
14.1. Market Position Analysis, by Company, 2019
14.2. Company Profiles
14.2.1. REGIQ SOLUTIONS
14.2.1.1. Company Overview (HQ, Business Segments, Employee Strength)
14.2.1.2. Growth Strategies
14.2.1.3. SWOT Analysis
14.2.2. LORENZ Life Sciences Group
14.2.2.1. Company Overview (HQ, Business Segments, Employee Strength)
14.2.2.2. Growth Strategies
14.2.2.3. SWOT Analysis
14.2.3. AxSource Consulting Inc
14.2.3.1. Company Overview (HQ, Business Segments, Employee Strength)
14.2.3.2. Growth Strategies
14.2.3.3. SWOT Analysis
14.2.4. Freyr
14.2.4.1. Company Overview (HQ, Business Segments)
14.2.4.2. Growth Strategies
14.2.4.3. SWOT Analysis
14.2.5. Promedica International
14.2.5.1. Company Overview (HQ, Business Segments, Employee Strength)
14.2.5.2. Growth Strategies
14.2.5.3. SWOT Analysis
14.2.6. Covance
14.2.6.1. Company Overview (HQ, Business Segments)
14.2.6.2. Growth Strategies
14.2.6.3. SWOT Analysis
14.2.7. Assent Compliance Inc
14.2.7.1. Company Overview (HQ, Business Segments)
14.2.7.2. Growth Strategies
14.2.7.3. SWOT Analysis
14.2.8. MakroCare
14.2.8.1. Company Overview (HQ, Business Segments, Employee Strength)
14.2.8.2. Growth Strategies
14.2.8.3. SWOT Analysis
14.2.9. EMERGO
14.2.9.1. Company Overview (HQ, Business Segments, Employee Strength)
14.2.9.2. Growth Strategies
14.2.9.3. SWOT Analysis
14.2.10. ICON plc
14.2.10.1. Company Overview (HQ, Business Segments, Employee Strength)
14.2.10.2. Company Financials
14.2.10.3. Growth Strategies
14.2.10.4. SWOT Analysis
List of TablesTable 01: Global Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Service, 2018–2030
Table 02: Global Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Software, 2018–2030
Table 03: Global Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Region, 2018–2030
Table 04: North America Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Country, 2018–2030
Table 05: North America Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Service, 2018–2030
Table 06: North America Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Software, 2018–2030
Table 07: Europe Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Country/Sub-Region, 2018–2030
Table 08: Europe Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Service, 2018–2030
Table 09: Europe Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Software, 2018–2030
Table 10: Asia Pacific Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Country/Sub-Region, 2018–2030
Table 11: Asia Pacific Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Service, 2018–2030
Table 12: Asia Pacific Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Software, 2018–2030
Table 13: Latin America Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Country/Sub-Region, 2018–2030
Table 14: Latin America Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Service, 2018–2030
Table 15: Latin America Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Software, 2018–2030
Table 16: Middle East & Africa Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Country/Sub-Region, 2018–2030
Table 17: Middle East & Africa Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Service, 2018–2030
Table 18: Middle East & Africa Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Software, 2018–2030
List of Figures
Figure 01: Global Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, 2018–2030
Figure 02: Global Medical Device & IVD Regulatory Affairs Outsourcing Market Value Share, by Service (2019)
Figure 03: Global Medical Device & IVD Regulatory Affairs Outsourcing Market Value Share, by Software (2019)
Figure 04: Global Medical Device & IVD Regulatory Affairs Outsourcing Market Value Share, by Region (2019)
Figure 05: Global Medical Device & IVD Regulatory Affairs Outsourcing Market Value Share Analysis, by Service, 2019 and 2030
Figure 06: Global Medical Device & IVD Regulatory Affairs Outsourcing Market Attractiveness Analysis, by Service, 2020–2030
Figure 07: Global Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn), by Regulatory Writing & Submissions, 2018–2030
Figure 08: Global Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn), by Regulatory Registration Service, 2018–2030
Figure 09: Global Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn), by Regulatory Consulting, 2018–2030
Figure 10: Global Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn), by Others, 2018–2030
Figure 11: Global Medical Device & IVD Regulatory Affairs Outsourcing Market Value Share Analysis, by Software, 2019 and 2030
Figure 12: Global Medical Device & IVD Regulatory Affairs Outsourcing Market Attractiveness Analysis, by Software, 2020–2030
Figure 13: Global Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn), by Cloud-based software, 2018–2030
Figure 14: Global Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn), by On-premises software, 2018–2030
Figure 15: Global Medical Device & IVD Regulatory Affairs Outsourcing Market Value Share Analysis, by Region, 2019 and 2030
Figure 16: Global Medical Device & IVD Regulatory Affairs Outsourcing Market Attractiveness Analysis, by Region
Figure 17: North America Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast and Y-o-Y Growth (%) Projection, 2018–2030
Figure 18: North America Medical Device & IVD Regulatory Affairs Outsourcing Market Value Share (%), by Country, 2019 and 2030
Figure 19: North America Medical Device & IVD Regulatory Affairs Outsourcing Market Attractiveness Analysis, by Country, 2020–2030
Figure 20: North America Medical Device & IVD Regulatory Affairs Outsourcing Market Value Share (%), by Service, 2019 and 2030
Figure 21: North America Medical Device & IVD Regulatory Affairs Outsourcing Market Attractiveness Analysis, by Service, 2020–2030
Figure 22: North America Medical Device & IVD Regulatory Affairs Outsourcing Market Value Share (%), by Software, 2019 and 2030
Figure 23: North America Medical Device & IVD Regulatory Affairs Outsourcing Market Attractiveness Analysis, by Software, 2020–2030
Figure 24: Europe Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast and Y-o-Y Growth (%) Projection, 2018–2030
Figure 25: Europe Medical Device & IVD Regulatory Affairs Outsourcing Market Value Share (%), by Country/Sub-region, 2019 and 2030
Figure 26: Europe Medical Device & IVD Regulatory Affairs Outsourcing Market Attractiveness Analysis, by Country/Sub-region, 2020–2030
Figure 27: Europe Medical Device & IVD Regulatory Affairs Outsourcing Market Value Share (%), by Service, 2019 and 2030
Figure 28: Europe Medical Device & IVD Regulatory Affairs Outsourcing Market Attractiveness Analysis, by Service, 2020–2030
Figure 29: Europe Medical Device & IVD Regulatory Affairs Outsourcing Market Value Share (%), by Software, 2019 and 2030
Figure 30: Europe Medical Device & IVD Regulatory Affairs Outsourcing Market Attractiveness Analysis, by Software, 2020–2030
Figure 31: Asia Pacific Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast and Y-o-Y Growth (%) Projection, 2018–2030
Figure 32: Asia Pacific Medical Device & IVD Regulatory Affairs Outsourcing Market Value Share (%), by Country/Sub-region, 2019 and 2030
Figure 33: Asia Pacific Medical Device & IVD Regulatory Affairs Outsourcing Market Attractiveness Analysis, by Country/Sub-region, 2020–2030
Figure 34: Asia Pacific Medical Device & IVD Regulatory Affairs Outsourcing Market Value Share (%), by Service, 2019 and 2030
Figure 35: Asia Pacific Medical Device & IVD Regulatory Affairs Outsourcing Market Attractiveness Analysis, by Service, 2020–2030
Figure 36: Asia Pacific Medical Device & IVD Regulatory Affairs Outsourcing Market Value Share (%), by Software, 2019 and 2030
Figure 37: Asia Pacific Medical Device & IVD Regulatory Affairs Outsourcing Market Attractiveness Analysis, by Software, 2020–2030
Figure 38: Latin America Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast and Y-o-Y Growth (%) Projection, 2018–2030
Figure 39: Latin America Medical Device & IVD Regulatory Affairs Outsourcing Market Value Share (%), by Country/Sub-Region, 2019 and 2030
Figure 40: Latin America Medical Device & IVD Regulatory Affairs Outsourcing Market Attractiveness Analysis, by Country/Sub-Region, 2020–2030
Figure 41: Latin America Medical Device & IVD Regulatory Affairs Outsourcing Market Value Share (%), by Service, 2019 and 2030
Figure 42: Latin America Medical Device & IVD Regulatory Affairs Outsourcing Market Attractiveness Analysis, by Service, 2020–2030
Figure 43: Latin America Medical Device & IVD Regulatory Affairs Outsourcing Market Value Share (%), by Software, 2019 and 2030
Figure 44: Latin America Medical Device & IVD Regulatory Affairs Outsourcing Market Attractiveness Analysis, by Software, 2020–2030
Figure 45: Middle East & Africa Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast and Y-o-Y Growth (%) Projection, 2018–2030
Figure 46: Middle East & Africa Medical Device & IVD Regulatory Affairs Outsourcing Market Value Share (%), by Country/Sub-Region, 2019 and 2030
Figure 47: Middle East & Africa Medical Device & IVD Regulatory Affairs Outsourcing Market Attractiveness Analysis, by Country/Sub-Region, 2020–2030
Figure 48: Middle East & Africa Medical Device & IVD Regulatory Affairs Outsourcing Market Value Share (%), by Service, 2019 and 2030
Figure 49: Middle East & Africa Medical Device & IVD Regulatory Affairs Outsourcing Market Attractiveness Analysis, by Service, 2020–2030
Figure 50: Middle East & Africa Medical Device & IVD Regulatory Affairs Outsourcing Market Value Share (%), by Software, 2019 and 2030
Figure 51: Middle East & Africa Medical Device & IVD Regulatory Affairs Outsourcing Market Attractiveness Analysis, by Software, 2020–2030
Figure 52: Market Position Analysis, 2019, by Tier and Size of Company
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