Medical Device Testing and Certification Market, By Service Type (Testing Services, Inspection Services, and Certification Services), By Sourcing Type (In-house and Outsourced), By Device Class (Class I, Class II, and Class III), By Technology (Active Imp

Medical Device Testing and Certification Market, By Service Type (Testing Services, Inspection Services, and Certification Services), By Sourcing Type (In-house and Outsourced), By Device Class (Class I, Class II, and Class III), By Technology (Active Implant Medical Device, Active Medical Device, Non-Active Medical Device, In-Vitro Diagnostic Medical Device, Ophthalmic Medical Device, Orthopedic and Dental Medical Device, Vascular Medical Device, and Other Technologies), and By Geography (North America, Europe, Asia Pacific, Latin America, and Middle East & Africa)- Size, Share, Outlook, and Opportunity Analysis, 2023 - 2030


Medical device testing and certification is necessary to ensure safety and effectiveness of medical devices. The U.S. follows the Food and Drug Administration (FDA) guidelines, Canada needs the Health Canada Registration, Europe considers Conformitè Europëenne (CE) approval, and India need approval from the Central Drugs Standard Control Organisation (CDSCO).

Market Dynamics:

Rise in focus on the medical device testing and certification, stringent government regulations, rise in integration of Artificial Intelligence (AI) and Internet of Things (IoT) in medical devices, and the outbreak of COVID-19 are major factors expected to drive growth of the global medical device testing and certification market during the forecast period.

For instance, in January 2022, TÜV SÜD expanded its medical device testing laboratory in New Brighton, Minnesota. The state-of-the-art laboratory will offer an end-to-end testing solution for all medical devices and will also provide a wide range of biological and chemical testing of medical devices that complements TÜV SÜD’s current active medical device testing capabilities.

Key features of the study:
  • This report provides in-depth analysis of the global medical device testing and certification market, and provides market size (US$ Million) and compound annual growth rate (CAGR %) for the forecast period (2023–2030), considering 2022 as the base year.
  • It elucidates potential revenue opportunities across different segments and explains attractive investment proposition matrices for this market.
  • This study also provides key insights about market drivers, restraints, opportunities, new product launches or approval, market trends, regional outlook, and competitive strategies adopted by key players.
  • It profiles key players in the global medical device testing and certification market based on the following parameters such as company highlights, products portfolio, key highlights, financial performance, and strategies.
  • Key companies covered as a part of this study include Medistri SA, BSI Group, GMED, IMQ Group SRL, TOXIKON, TÜV SÜD, WuXi AppTec, Pace Analytical Services LLC, Gateway Analytical LLC, Boston Analytical, Bureau Veritas, UL LLC, TUV Rheinland, SGS SA, Intertek Group PLC, Eurofins Scientific, Element Materials Technology, Dekra Testing and Certification GmbH, Ente Certificazione Macchine, and Institute for testing and Certification Inc., among others.
  • Insights from this report would allow marketers and the management authorities of the companies to make informed decisions regarding their future product launches, type up-gradation, market expansion, and marketing tactics.
  • The global medical device testing and certification market report caters to various stakeholders in this industry including investors, suppliers, product manufacturers, distributors, new entrants, and financial analysts.
  • Stakeholders would have ease in decision-making through various strategy matrices used in analyzing the global medical device testing and certification market.
Detailed Segmentation:
  • Global Medical Device Testing and Certification Market, By Service Type
  • Testing Services
  • Inspection Services
  • Certification Services
  • Global Medical Device Testing and Certification Market, By Sourcing Type
  • In-house
  • Outsourced
  • Global Medical Device Testing and Certification Market, By Device Class
  • Class I
  • Class II
  • Class III
  • Global Medical Device Testing and Certification Market, By Technology
  • Active Implant Medical Device
  • Active Medical Device
  • Non-Active Medical Device
  • In-Vitro Diagnostic Medical Device
  • Ophthalmic Medical Device
  • Orthopedic and Dental Medical Device
  • Vascular Medical Device
  • Other Technologies
  • Global Medical Device Testing and Certification Market, By Geography
  • North America
  • Europe
  • Asia Pacific
  • Latin America
  • Middle East & Africa
  • Company Profiles
  • Medistri SA
  • BSI Group
  • Ente Certificazione Macchine
  • GMED
  • IMQ Group SRL
  • TOXIKON
  • TÜV SÜD
  • WuXi AppTec
  • Pace Analytical Services LLC
  • Gateway Analytical LLC
  • Boston Analytical
  • Bureau Veritas
  • UL LLC
  • TUV Rheinland
  • SGS SA
  • Intertek Group PLC
  • Eurofins Scientific
  • Element Materials Technology
  • Dekra Testing and Certification GmbH
  • Institute for testing and Certification Inc.


1. Research Objectives and Assumptions
Research Objectives
Assumptions
Abbreviations
2. Market Purview
Report Description
Market Definition and Scope
Executive Summary
Market Snapshot, By Services Type
Market Snapshot, By Sourcing Type
Market Snapshot, By Device Class
Market Snapshot, By Technology
Market Snapshot, By Geography
Coherent Opportunity Map (COM)
3. Market Dynamics, Regulations, and Trends Analysis
Market Dynamics
Stringent rules and regulations
Diversity in regulations
Outbreak of COVID-19 (pandemic)
Impact Analysis
Key Highlights
Regulatory Scenario
Product launch/Approvals
PEST Analysis
PORTER’s Analysis
Merger and Acquisition Scenario
4. Global Medical Device Testing and Certification Market – Impact of Coronavirus (COVID-19) Pandemic
COVID-19 Epidemiology
Supply Side and Demand Side Analysis
Economic Impact
5. Global Medical Device Testing and Certification Market, By Service Type, 2023-2030, (US$ Mn)
Introduction
Market Share Analysis, 2023 and 2030 (%)
Y-o-Y Growth Analysis, 2017 – 2030
Segment Trends
Testing Services
Introduction
Market Size and Forecast, and Y-o-Y Growth, 2023-2030,(US$ Mn)
Inspection Services
Introduction
Market Size and Forecast, and Y-o-Y Growth, 2023-2030,(US$ Mn)
Certification Services
Introduction
Market Size and Forecast, and Y-o-Y Growth, 2023-2030,(US$ Mn)
6. Global Medical Device Testing and Certification Market, By Sourcing Type, 2023-2030, (US$ Mn)
Introduction
Market Share Analysis, 2023 and 2030 (%)
Y-o-Y Growth Analysis, 2017 – 2030
Segment Trends
In-house
Introduction
Market Size and Forecast, and Y-o-Y Growth, 2023-2030,(US$ Mn)
Outsourced
Introduction
Market Size and Forecast, and Y-o-Y Growth, 2023-2030,(US$ Mn)
7. Global Medical Device Testing and Certification Market, By Device Class, 2023-2030, (US$ Mn)
Introduction
Market Share Analysis, 2023 and 2030 (%)
Y-o-Y Growth Analysis, 2017 – 2030
Segment Trends
Class I
Introduction
Market Size and Forecast, and Y-o-Y Growth, 2023-2030,(US$ Mn)
Class II
Introduction
Market Size and Forecast, and Y-o-Y Growth, 2023-2030,(US$ Mn)
Class III
Introduction
Market Size and Forecast, and Y-o-Y Growth, 2023-2030,(US$ Mn)
8. Global Medical Device Testing and Certification Market, By Technology, 2023-2030, (US$ Mn)
Introduction
Market Share Analysis, 2023 and 2030 (%)
Y-o-Y Growth Analysis, 2017 – 2030
Segment Trends
Active Implant Medical Device
Introduction
Market Size and Forecast, and Y-o-Y Growth, 2023-2030,(US$ Mn)
Active Medical Device
Introduction
Market Size and Forecast, and Y-o-Y Growth, 2023-2030,(US$ Mn)
Non-Active Medical Device
Introduction
Market Size and Forecast, and Y-o-Y Growth, 2023-2030,(US$ Mn)
In-Vitro Diagnostic Medical Device
Introduction
Market Size and Forecast, and Y-o-Y Growth, 2023-2030,(US$ Mn)
Ophthalmic Medical Device
Introduction
Market Size and Forecast, and Y-o-Y Growth, 2023-2030,(US$ Mn)
Orthopedic and Dental Medical Device
Introduction
Market Size and Forecast, and Y-o-Y Growth, 2023-2030,(US$ Mn)
Vascular Medical Device
Introduction
Market Size and Forecast, and Y-o-Y Growth, 2023-2030,(US$ Mn)
Other Technologies
Introduction
Market Size and Forecast, and Y-o-Y Growth, 2023-2030,(US$ Mn)
9. Global Medical Device Testing and Certification Market, By Geography, 2023-2030, (US$ Mn)
Introduction
Market Share Analysis, 2023 and 2030 (%)
Y-o-Y Growth Analysis, 2017 – 2030
Segment Trends
North America
Introduction
Market Size and Forecast, and Y-o-Y Growth, By Services Type, 2023-2030,(US$ Mn)
Market Size and Forecast, and Y-o-Y Growth, By Sourcing Type, 2023-2030,(US$ Mn)
Market Size and Forecast, and Y-o-Y Growth, By Device Class, 2023-2030,(US$ Mn)
Market Size and Forecast, and Y-o-Y Growth, By Technology, 2023-2030,(US$ Mn)
Europe
Introduction
Market Size and Forecast, and Y-o-Y Growth, By Services Type, 2023-2030,(US$ Mn)
Market Size and Forecast, and Y-o-Y Growth, By Sourcing Type, 2023-2030,(US$ Mn)
Market Size and Forecast, and Y-o-Y Growth, By Device Class, 2023-2030,(US$ Mn)
Market Size and Forecast, and Y-o-Y Growth, By Technology, 2023-2030,(US$ Mn)
Asia Pacific
Introduction
Market Size and Forecast, and Y-o-Y Growth, By Services Type, 2023-2030,(US$ Mn)
Market Size and Forecast, and Y-o-Y Growth, By Sourcing Type, 2023-2030,(US$ Mn)
Market Size and Forecast, and Y-o-Y Growth, By Device Class, 2023-2030,(US$ Mn)
Market Size and Forecast, and Y-o-Y Growth, By Technology, 2023-2030,(US$ Mn)
Latin America
Introduction
Market Size and Forecast, and Y-o-Y Growth, By Services Type, 2023-2030,(US$ Mn)
Market Size and Forecast, and Y-o-Y Growth, By Sourcing Type, 2023-2030,(US$ Mn)
Market Size and Forecast, and Y-o-Y Growth, By Device Class, 2023-2030,(US$ Mn)
Market Size and Forecast, and Y-o-Y Growth, By Technology, 2023-2030,(US$ Mn)
Middle East & Africa
Introduction
Market Size and Forecast, and Y-o-Y Growth, By Services Type, 2023-2030,(US$ Mn)
Market Size and Forecast, and Y-o-Y Growth, By Sourcing Type, 2023-2030,(US$ Mn)
Market Size and Forecast, and Y-o-Y Growth, By Device Class, 2023-2030,(US$ Mn)
Market Size and Forecast, and Y-o-Y Growth, By Technology, 2023-2030,(US$ Mn)
10. Competitive Landscape
Medistri SA
Company Highlights
Product Portfolio
Key Developments
Financial Performance
Strategies
BSI Group
Ente Certificazione Macchine
GMED
IMQ Group SRL
TOXIKON
TÜV SÜD
WuXi AppTec
Pace Analytical Services LLC
Gateway Analytical LLC
Boston Analytical
Bureau Veritas
UL LLC
TUV Rheinland
SGS SA
Intertek Group PLC
Eurofins Scientific
Element Materials Technology
Dekra Testing and Certification GmbH
Institute for testing and Certification Inc.
Analyst Views
11. Section
Research Methodology
About us
*Browse 24 market data tables and 28 figures on "Global Medical Device Testing and Certification Market” - forecast to 2030

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