Table of Content



Chapter 1 Methodology and Scope
1.1 Market Segmentation & Scope
1.1.1 Estimates And Forecast Timeline
1.2 Research Methodology
1.3 Information Procurement
1.3.1 Purchased Database
1.3.2 Gvr’s Internal Database
1.3.3 Secondary Sources
1.3.4 Primary Research
1.3.5 Details Of Primary Research
1.4 Information or Data Analysis
1.4.1 Data Analysis Models
1.5 Market Formulation & Validation
1.6 Region Wise Market Calculation
1.6.1 Region Wise Market: Base Estimates
1.6.2 Global Market: CAGR Calculation
1.7 List of Secondary Sources
1.8 Objectives
1.8.1 Objective - 1: Understanding market dynamics
1.8.2 Objective - 2: Understanding market estimates and forecasts
1.8.3 Objective - 3: Understanding attributes such as strategy framework and competitor categorization
1.8.4 Objective - 4: Understanding the key service and application scopes to conclude on the market size.
Chapter 2 Executive Summary
2.1 Market Outlook
Chapter 3 Medical Device Regulatory Affairs Market: Variables, Trends, & Scope
3.1 Market Segmentation and Scope
3.2 Market Dynamics
3.2.1 Market Driver Analysis
3.2.1.1 Changing regulatory landscape
3.2.1.2 Entry of companies in the global market
3.2.1.3 Life science companies focusing on their core competencies
3.2.1.4 Economic and competitive pressures
3.2.1.5 Demand for faster approval process for breakthrough drugs and devices
3.2.1.6 Growth in emerging areas such as personalized medicine, biosimilars, and orphan drugs
3.2.2 Market Restraint Analysis
3.2.2.1 Risk associated with data security
3.2.2.2 Monitoring issues and lack of standardization
3.3 Penetration & Growth Prospect Mapping
3.4 COVID-19 Impact on the Market
3.5 Major Deals and Strategic Alliances Analysis
3.6 Medical Device Regulatory Affairs: Market Analysis Tools
3.6.1 Industry Analysis - Porter’s
3.6.2 PESTEL Analysis
Chapter 4 Medical Device Regulatory Affairs Market: Service Segment Analysis
4.1 Medical Device Regulatory Affairs Market: Service Market Share Analysis, 2020 & 2028
4.2 Regulatory Consulting
4.2.1 Regulatory Consulting Market, 2016 - 2028 (USD Million)
4.3 Legal Representation
4.3.1 Legal Representation Market, 2016 - 2028 (USD Million)
4.4 Regulatory Writing and Publishing
4.4.1 Regulatory Writing and Publishing Market, 2016 - 2028 (USD Million)
4.5 Product Registration and Clinical Trial Application
4.5.1 Product Registration and Clinical Trial Application Market, 2016 - 2028 (USD Million)
4.6 Other Regulatory Services
4.6.1 Other Regulatory Services Market, 2016 - 2028 (USD Million)
Chapter 5 Medical Device Regulatory Affairs Market: Type Segment Analysis
5.1 Medical Device Regulatory Affairs Market: Type Market Share Analysis, 2020 & 2028
5.2 Diagnostics
5.2.1 Diagnostic Medical Device Regulatory Affairs Market, 2016 - 2028 (USD Million)
5.3 Therapeutics
5.3.1 Therapeutics Medical Device Regulatory Affairs Market, 2016 - 2028 (USD Million)
Chapter 6 Medical Device Regulatory Affairs Market: Service Provider Segment Analysis
6.1 Medical Device Regulatory Affairs Market: Service Provider Market Share Analysis, 2020 & 2028
6.2 Outsource
6.2.1 Outsource Medical Device Regulatory Affairs Market, 2016 - 2028 (USD Million)
6.3 In-house
6.3.1 In-house Medical Device Regulatory Affairs Market, 2016 - 2028 (USD Million)
Chapter 7 Medical Device Regulatory Affairs Market: Regional Analysis
7.1 Medical Device Regulatory Affairs Market: Regional Market Share Analysis, 2020 & 2028
7.2 North America
7.2.1 North America Medical Device Regulatory Affairs Market, 2016 - 2028 (USD Million)
7.2.2 U.S.
7.2.2.1 U.S. Medical Device Regulatory Affairs Market, 2016 - 2028 (USD Million)
7.2.3 Canada
7.2.3.1 Canada Medical Device Regulatory Affairs Market, 2016 - 2028 (USD Million)
7.3 Europe
7.3.1 Europe Medical Device Regulatory Affairs Market, 2016 - 2028 (USD Million)
7.3.2 U.K.
7.3.2.1 U.K. Medical Device Regulatory Affairs Market, 2016 - 2028 (USD Million)
7.3.3 Germany
7.3.3.1 Germany Medical Device Regulatory Affairs Market, 2016 - 2028 (USD Million)
7.3.4 France
7.3.4.1 France Medical Device Regulatory Affairs Market, 2016 - 2028 (USD Million)
7.3.5 Italy
7.3.5.1 Italy Medical Device Regulatory Affairs Market, 2016 - 2028 (USD Million)
7.3.6 Spain
7.3.6.1 Spain Medical Device Regulatory Affairs Market, 2016 - 2028 (USD Million)
7.4 Asia Pacific
7.4.1 Asia Pacific Medical Device Regulatory Affairs Market, 2016 - 2028 (USD Million)
7.4.2 Japan
7.4.2.1 Japan Medical Device Regulatory Affairs Market, 2016 - 2028 (USD Million)
7.4.3 China
7.4.3.1 China Medical Device Regulatory Affairs Market, 2016 - 2028 (USD Million)
7.4.4 India
7.4.4.1 India Medical Device Regulatory Affairs Market, 2016 - 2028 (USD Million)
7.4.5 Australia
7.4.5.1 Australia Medical Device Regulatory Affairs Market, 2016 - 2028 (USD Million)
7.4.6 South Korea
7.4.6.1 South Korea Medical Device Regulatory Affairs Market, 2016 - 2028 (USD Million)
7.5 Latin America
7.5.1 Latin America Medical Device Regulatory Affairs Market, 2016 - 2028 (USD Million)
7.5.2 Brazil
7.5.2.1 Brazil Medical Device Regulatory Affairs Market, 2016 - 2028 (USD Million)
7.5.3 Mexico
7.5.3.1 Mexico Medical Device Regulatory Affairs Market, 2016 - 2028 (USD Million)
7.5.4 Argentina
7.5.4.1 Argentina Medical Device Regulatory Affairs Market, 2016 - 2028 (USD Million)
7.5.5 Colombia
7.5.5.1 Colombia Medical Device Regulatory Affairs Market, 2016 - 2028 (USD Million)
7.6 MEA
7.6.1 MEA Medical Device Regulatory Affairs Market, 2016 - 2028 (USD Million)
7.6.2 South Africa
7.6.2.1 South Africa Medical Device Regulatory Affairs Market, 2016 - 2028 (USD Million)
7.6.3 Saudi Arabia
7.6.3.1 Saudi Arabia Medical Device Regulatory Affairs Market, 2016 - 2028 (USD Million)
7.6.4 UAE
7.6.4.1 UAE Medical Device Regulatory Affairs Market, 2016 - 2028 (USD Million)
Chapter 8 Company Profiles
8.1 ICON, Plc
8.1.1 Company Overview
8.1.2 Service Benchmarking
8.1.3 Financial Performance
8.1.4 Strategic Intiatives
8.2 Emergo
8.2.1 Company Overview
8.2.2 Financial Performance
8.2.3 Service Benchmarking
8.2.4 Strategic Initiatives
8.3 Freyr
8.3.1 Company Overview
8.3.2 Service Benchmarking
8.3.3 Strategic Initiatives
8.4 Covance, Inc.
8.4.1 Company Overview
8.4.2 Financial Performance
8.4.3 Service Benchmarking
8.5 IQVIA
8.5.1 Company Overview
8.5.2 Financial Performance
8.5.3 Service Benchmarking
8.6 Intertek
8.6.1 Company Overview
8.6.2 Financial Performance
8.6.3 Service Benchmarking
8.7 SGS SA
8.7.1 Company Overview
8.7.2 Financial Performance
8.7.3 Service Benchmarking
8.7.4 Strategic Initiatives
8.8 Promedica International
8.8.1 Company Overview
8.8.2 Financial Performance
8.8.3 Service Benchmarking
8.9 Integer Holdings, Inc.
8.9.1 Company Overview
8.9.2 Financial Performance
8.9.3 Service Benchmarking
8.9.4 Strategic Initiatives
8.9.5 Strategic Initiatives
8.10 Medpace
8.10.1 Company Overview
8.10.2 Financial Performance
8.10.3 Service Benchmarking



List of Figures



Fig. 1 Market research process
Fig. 2 Information procurement
Fig. 3 Primary research pattern
Fig. 4 Market research approaches
Fig. 5 Value-chain-based sizing & forecasting
Fig. 6 QFD modeling for market share assessment
Fig. 7 Market formulation & validation
Fig. 8 Medical device regulatory affairs market snapshot (2020)
Fig. 9 Medical device regulatory affairs market segmentation
Fig. 10 Market driver relevance analysis (Current & future impact)
Fig. 11 Market restraint relevance analysis (Current & future impact)
Fig. 12 Penetration & growth prospect mapping
Fig. 13 Porter’s five forces analysis
Fig. 14 PESTEL analysis
Fig. 15 Medical device regulatory affairs market service outlook: Segment dashboard
Fig. 16 Medical device regulatory affairs market: service movement analysis
Fig. 17 Regulatory consulting market, 2016 - 2028 (USD Million)
Fig. 18 Legal representation market, 2016 - 2028 (USD Million)
Fig. 19 Regulatory writing and publishing market, 2016 - 2028 (USD Million)
Fig. 20 Product registration and clinical trial application market, 2016 - 2028 (USD Million)
Fig. 21 Other regulatory services market, 2016 - 2028 (USD Million)
Fig. 22 Medical device regulatory affairs type outlook: Segment dashboard
Fig. 23 Medical device regulatory affairs market: Type movement analysis
Fig. 24 Diagnostics based medical device regulatory affairs market, 2016 - 2028 (USD Million)
Fig. 25 Therapeutic based medical device regulatory affairs market, 2016 - 2028 (USD Million)
Fig. 26 Medical device regulatory affairs service provider outlook: Segment dashboard
Fig. 27 Medical device regulatory affairs market: Service provider movement analysis
Fig. 28 Outsource based medical device regulatory affairs market, 2016 - 2028 (USD Million)
Fig. 29 In-house based medical device regulatory affairs market, 2016 - 2028 (USD Million)
Fig. 30 Regional market: Key takeaways
Fig. 31 Regional outlook, 2020 & 2028
Fig. 32 North America market, 2016 - 2028 (USD Million)
Fig. 33 U.S. market, 2016 - 2028 (USD Million)
Fig. 34 Canada market, 2016 - 2028 (USD Million)
Fig. 35 Europe market, 2016 - 2028 (USD Million)
Fig. 36 U.K. market, 2016 - 2028 (USD Million)
Fig. 37 Germany market, 2016 - 2028 (USD Million)
Fig. 38 France market, 2016 - 2028 (USD Million)
Fig. 39 Italy market, 2016 - 2028 (USD Million)
Fig. 40 Spain market, 2016 - 2028 (USD Million)
Fig. 41 Asia Pacific market, 2016 - 2028 (USD Million)
Fig. 42 Japan market, 2016 - 2028 (USD Million)
Fig. 43 China market, 2016 - 2028 (USD Million)
Fig. 44 India market, 2016 - 2028 (USD Million)
Fig. 45 Australia market, 2016 - 2028 (USD Million)
Fig. 46 South Korea market, 2016 - 2028 (USD Million)
Fig. 47 Latin America market, 2016 - 2028 (USD Million)
Fig. 48 Brazil market, 2016 - 2028 (USD Million)
Fig. 49 Mexico market, 2016 - 2028 (USD Million)
Fig. 50 Argentina market, 2016 - 2028 (USD Million)
Fig. 51 Colombia market, 2016 - 2028 (USD Million)
Fig. 52 MEA market, 2016 - 2028 (USD Million)
Fig. 53 South Africa market, 2016 - 2028 (USD Million)
Fig. 54 Saudi Arabia market, 2016 - 2028 (USD Million)
Fig. 55 UAE market, 2016 - 2028 (USD Million)


List of Tables



Table 1 List of Secondary Sources
Table 2 List of Abbreviations
Table 3 Global Medical Device Regulatory Affairs Market, by Region, 2016 - 2028 (USD Million)
Table 4 Global Medical Device Regulatory Affairs Market, by Service, 2016 - 2028 (USD Million)
Table 5 Global Medical Device Regulatory Affairs Market, by Type, 2016 - 2028 (USD Million)
Table 6 Global Medical Device Regulatory Affairs Market, by Service Provider, 2016 - 2028 (USD Million)
Table 7 North America Medical Device Regulatory Affairs Market, by Country, 2016 - 2028 (USD Million)
Table 8 North America Medical Device Regulatory Affairs Market, by Service, 2016 - 2028 (USD Million)
Table 9 North America Medical Device Regulatory Affairs Market, by Type, 2016 - 2028 (USD Million)
Table 10 North America Medical Device Regulatory Affairs Market, by Service Provider, 2016 - 2028 (USD Million)
Table 11 U.S. Medical Device Regulatory Affairs Market, by Service, 2016 - 2028 (USD Million)
Table 12 U.S. Medical Device Regulatory Affairs Market, by Type, 2016 - 2028 (USD Million)
Table 13 U.S. Medical Device Regulatory Affairs Market, by Service Provider, 2016 - 2028 (USD Million)
Table 14 Canada Medical Device Regulatory Affairs Market, by Service, 2016 - 2028 (USD Million)
Table 15 Canada Medical Device Regulatory Affairs Market, by Type, 2016 - 2028 (USD Million)
Table 16 Canada Medical Device Regulatory Affairs Market, by Service Provider, 2016 - 2028 (USD Million)
Table 17 Europe Medical Device Regulatory Affairs Market, by Country, 2016 - 2028 (USD Million)
Table 18 Europe Medical Device Regulatory Affairs Market, by Service, 2016 - 2028 (USD Million)
Table 19 Europe Medical Device Regulatory Affairs Market, by Type, 2016 - 2028 (USD Million)
Table 20 Europe Medical Device Regulatory Affairs Market, by Service Provider, 2016 - 2028 (USD Million)
Table 21 U.K. Medical Device Regulatory Affairs Market, by Service, 2016 - 2028 (USD Million)
Table 22 U.K. Medical Device Regulatory Affairs Market, by Type, 2016 - 2028 (USD Million)
Table 23 U.K. Medical Device Regulatory Affairs Market, by Service Provider, 2016 - 2028 (USD Million)
Table 24 Germany Medical Device Regulatory Affairs Market, by Service, 2016 - 2028 (USD Million)
Table 25 Germany Medical Device Regulatory Affairs Market, by Type, 2016 - 2028 (USD Million)
Table 26 Germany Medical Device Regulatory Affairs Market, by Service Provider, 2016 - 2028 (USD Million)
Table 27 France Medical Device Regulatory Affairs Market, by Service, 2016 - 2028 (USD Million)
Table 28 France Medical Device Regulatory Affairs Market, by Type, 2016 - 2028 (USD Million)
Table 29 France Medical Device Regulatory Affairs Market, by Service Provider, 2016 - 2028 (USD Million)
Table 30 Italy Medical Device Regulatory Affairs Market, by Service, 2016 - 2028 (USD Million)
Table 31 Italy Medical Device Regulatory Affairs Market, by Type, 2016 - 2028 (USD Million)
Table 32 Italy Medical Device Regulatory Affairs Market, by Service Provider, 2016 - 2028 (USD Million)
Table 33 Spain Medical Device Regulatory Affairs Market, by Service, 2016 - 2028 (USD Million)
Table 34 Spain Medical Device Regulatory Affairs Market, by Type, 2016 - 2028 (USD Million)
Table 35 Spain Medical Device Regulatory Affairs Market, by Service Provider, 2016 - 2028 (USD Million)
Table 36 Asia Pacific Medical Device Regulatory Affairs Market, by Country, 2016 - 2028 (USD Million)
Table 37 Asia Pacific Medical Device Regulatory Affairs Market, by Service, 2016 - 2028 (USD Million)
Table 38 Asia Pacific Medical Device Regulatory Affairs Market, by Type, 2016 - 2028 (USD Million)
Table 39 Asia Pacific Medical Device Regulatory Affairs Market, by Service Provider, 2016 - 2028 (USD Million)
Table 40 India Medical Device Regulatory Affairs Market, by Service, 2016 - 2028 (USD Million)
Table 41 India Medical Device Regulatory Affairs Market, by Type, 2016 - 2028 (USD Million)
Table 42 India Medical Device Regulatory Affairs Market, by Service Provider, 2016 - 2028 (USD Million)
Table 43 Japan Medical Device Regulatory Affairs Market, by Service, 2016 - 2028 (USD Million)
Table 44 Japan Medical Device Regulatory Affairs Market, by Type, 2016 - 2028 (USD Million)
Table 45 Japan Medical Device Regulatory Affairs Market, by Service Provider, 2016 - 2028 (USD Million)
Table 46 China Medical Device Regulatory Affairs Market, by Service, 2016 - 2028 (USD Million)
Table 47 China Medical Device Regulatory Affairs Market, by Type, 2016 - 2028 (USD Million)
Table 48 China Medical Device Regulatory Affairs Market, by Service Provider, 2016 - 2028 (USD Million)
Table 49 Australia Medical Device Regulatory Affairs Market, by Service, 2016 - 2028 (USD Million)
Table 50 Australia Medical Device Regulatory Affairs Market, by Type, 2016 - 2028 (USD Million)
Table 51 Australia Medical Device Regulatory Affairs Market, by Service Provider, 2016 - 2028 (USD Million)
Table 52 South Korea Medical Device Regulatory Affairs Market, by Service, 2016 - 2028 (USD Million)
Table 53 South Korea Medical Device Regulatory Affairs Market, by Type, 2016 - 2028 (USD Million)
Table 54 South Korea Medical Device Regulatory Affairs Market, by Service Provider, 2016 - 2028 (USD Million)
Table 55 Latin America Medical Device Regulatory Affairs Market, by Country, 2016 - 2028 (USD Million)
Table 56 Latin America Medical Device Regulatory Affairs Market, by Service, 2016 - 2028 (USD Million)
Table 57 Latin America Medical Device Regulatory Affairs Market, by Type, 2016 - 2028 (USD Million)
Table 58 Latin America Medical Device Regulatory Affairs Market, by Service Provider, 2016 - 2028 (USD Million)
Table 59 Brazil Medical Device Regulatory Affairs Market, by Service, 2016 - 2028 (USD Million)
Table 60 Brazil Medical Device Regulatory Affairs Market, by Type, 2016 - 2028 (USD Million)
Table 61 Brazil Medical Device Regulatory Affairs Market, by Service Provider, 2016 - 2028 (USD Million)
Table 62 Mexico Medical Device Regulatory Affairs Market, by Service, 2016 - 2028 (USD Million)
Table 63 Mexico Medical Device Regulatory Affairs Market, by Type, 2016 - 2028 (USD Million)
Table 64 Mexico Medical Device Regulatory Affairs Market, by Service Provider, 2016 - 2028 (USD Million)
Table 65 Argentina Medical Device Regulatory Affairs Market, by Service, 2016 - 2028 (USD Million)
Table 66 Argentina Medical Device Regulatory Affairs Market, by Type, 2016 - 2028 (USD Million)
Table 67 Argentina Medical Device Regulatory Affairs Market, by Service Provider, 2016 - 2028 (USD Million)
Table 68 Colombia Medical Device Regulatory Affairs Market, by Service, 2016 - 2028 (USD Million)
Table 69 Colombia Medical Device Regulatory Affairs Market, by Type, 2016 - 2028 (USD Million)
Table 70 Colombia Medical Device Regulatory Affairs Market, by Service Provider, 2016 - 2028 (USD Million)
Table 71 Middle East & Africa Medical Device Regulatory Affairs Market, by Country, 2016 - 2028 (USD Million)
Table 72 Middle East & Africa Medical Device Regulatory Affairs Market, by Service, 2016 - 2028 (USD Million)
Table 73 Middle East & Africa Medical Device Regulatory Affairs Market, by Type, 2016 - 2028 (USD Million)
Table 74 Middle East & Africa Medical Device Regulatory Affairs Market, by Service Provider, 2016 - 2028 (USD Million)
Table 75 South Korea Medical Device Regulatory Affairs Market, by Service, 2016 - 2028 (USD Million)
Table 76 South Korea Medical Device Regulatory Affairs Market, by Type, 2016 - 2028 (USD Million)
Table 77 South Korea Medical Device Regulatory Affairs Market, by Service Provider, 2016 - 2028 (USD Million)
Table 78 Saudi Arabia Medical Device Regulatory Affairs Market, by Service, 2016 - 2028 (USD Million)
Table 79 Saudi Arabia Medical Device Regulatory Affairs Market, by Type, 2016 - 2028 (USD Million)
Table 80 Saudi Arabia Medical Device Regulatory Affairs Market, by Service Provider, 2016 - 2028 (USD Million)
Table 81 UAE Medical Device Regulatory Affairs Market, by Service, 2016 - 2028 (USD Million)
Table 82 UAE Medical Device Regulatory Affairs Market, by Type, 2016 - 2028 (USD Million)
Table 83 UAE Medical Device Regulatory Affairs Market, by Service Provider, 2016 - 2028 (USD Million)