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.