1. Preface
1.1. Objectives of the Study
1.2. Market Segmentation & Coverage
1.3. Years Considered for the Study
1.4. Currency & Pricing
1.5. Language
1.6. Limitations
1.7. Assumptions
1.8. Stakeholders
2. Research Methodology
2.1. Define: Research Objective
2.2. Determine: Research Design
2.3. Prepare: Research Instrument
2.4. Collect: Data Source
2.5. Analyze: Data Interpretation
2.6. Formulate: Data Verification
2.7. Publish: Research Report
2.8. Repeat: Report Update
3. Executive Summary
4. Market Overview
4.1. Introduction
4.2. Medical Device Testing Market, by Region
5. Market Insights
5.1. Market Dynamics
5.1.1. Drivers
5.1.1.1. Increasing requirements for new medical devices to undergo rigorous regulatory standards
5.1.1.2. Government initiatives to establish and strengthen medical device manufacturing and testing facilities
5.1.1.3. Increasing trend of outsourcing medical device testing services
5.1.2. Restraints
5.1.2.1. Extended lead time and costs associated with qualification tests
5.1.3. Opportunities
5.1.3.1. Emerging potential for cybersecurity testing with the advent of smart medical devices
5.1.3.2. Ongoing introduction of new medical device testing services and facilities
5.1.4. Challenges
5.1.4.1. Complexities associated with medical device testing
5.2. Market Segmentation Analysis
5.2.1. Service Type: Growing requirement for inspection services driven by the ever-growing complexity and diversity of medical technologies
5.2.2. Test Type: Emerging applications of cybersecurity testing with advent of advanced technologies in medical devices
5.2.3. Device Class: Requirement of rigorous PMA processes for class III devices to ensure safety and effectiveness before reaching the market
5.2.4. Technology: Escalating adoption of medical device testing services for mobile devices
5.2.5. Phase: Significant penetration of medical devices testing in the clinical phase
5.2.6. Sourcing Type: Higher preferences for in-house testing for highly proprietary or sensitive devices
5.2.7. End-Users: Proliferating need from medical device manufacturers
5.3. Market Trend Analysis
5.3.1. Innovations and developments in smart medical devices creating need for medical device testing services in the Americas
5.3.2. Substantial focus on domestic production and exports of medical devices raising the need for robust medical device testing services in the APAC region
5.3.3. Presence of well-established regulations governing medical devices elevating the need for medical device testing services in the EMEA region
5.4. Cumulative Impact of High Inflation
5.5. Porter’s Five Forces Analysis
5.5.1. Threat of New Entrants
5.5.2. Threat of Substitutes
5.5.3. Bargaining Power of Customers
5.5.4. Bargaining Power of Suppliers
5.5.5. Industry Rivalry
5.6. Value Chain & Critical Path Analysis
5.7. Regulatory Framework
6. Medical Device Testing Market, by Service Type
6.1. Introduction
6.2. Certification Services
6.3. Inspection Services
6.4. Testing Services
7. Medical Device Testing Market, by Test Type
7.1. Introduction
7.2. Chemical, Physical, & Biocompatibility Testing
7.3. Cybersecurity Testing
7.4. Electrical Safety
7.5. Environmental Testing
7.6. Mechanical Testing
8. Medical Device Testing Market, by Device Class
8.1. Introduction
8.2. Class I
8.3. Class II
8.4. Class III
9. Medical Device Testing Market, by Phase
9.1. Introduction
9.2. Clinical
9.3. Preclinical
10. Medical Device Testing Market, by Device Type
10.1. Introduction
10.2. Active Implant Medical Device
10.3. Active Medical Device
10.4. In-Vitro Diagnostic Medical Device
10.5. Mobile Medical Devices
10.6. Non-Active Medical Device
10.7. Ophthalmic Medical Device
10.8. Orthopedic & Dental Medical Device
10.9. Vascular Medical Device
11. Medical Device Testing Market, by Sourcing Type
11.1. Introduction
11.2. In-House
11.3. Outsourced
12. Medical Device Testing Market, by End-Users
12.1. Introduction
12.2. Contract Manufacturing Organization
12.3. Medical Device Manufacturers
12.4. Research Institutions
13. Americas Medical Device Testing Market
13.1. Introduction
13.2. Argentina
13.3. Brazil
13.4. Canada
13.5. Mexico
13.6. United States
14. Asia-Pacific Medical Device Testing Market
14.1. Introduction
14.2. Australia
14.3. China
14.4. India
14.5. Indonesia
14.6. Japan
14.7. Malaysia
14.8. Philippines
14.9. Singapore
14.10. South Korea
14.11. Taiwan
14.12. Thailand
14.13. Vietnam
15. Europe, Middle East & Africa Medical Device Testing Market
15.1. Introduction
15.2. Denmark
15.3. Egypt
15.4. Finland
15.5. France
15.6. Germany
15.7. Israel
15.8. Italy
15.9. Netherlands
15.10. Nigeria
15.11. Norway
15.12. Poland
15.13. Qatar
15.14. Russia
15.15. Saudi Arabia
15.16. South Africa
15.17. Spain
15.18. Sweden
15.19. Switzerland
15.20. Turkey
15.21. United Arab Emirates
15.22. United Kingdom
16. Competitive Landscape
16.1. FPNV Positioning Matrix
16.2. Market Share Analysis, By Key Player
16.3. Competitive Scenario Analysis, By Key Player
16.3.1. Merger & Acquisition
16.3.1.1. Element Materials Technology Expands Connected Technology Testing Capabilities with Acquisition of CTK
16.3.1.2. Element Materials Technology Acquires National Technical Systems
16.3.1.3. Clinimark Acquired by Element Materials Technology
16.3.2. Agreement, Collaboration, & Partnership
16.3.2.1. MedCrypt and Stratigos Security Partner to Offer Specialized Penetration Testing and Security Assessments for Life-Saving Medical Devices
16.3.2.2. New Alliance Enables Medical Device OEMs With End-To-End AM Solution
16.3.2.3. Molbio Diagnostics Partners with SigTuple To Build Next-Gen Point-Of-Care Diagnostic Testing Devices
16.3.2.4. DDL and Gateway Analytical Announce Joint Agreement
16.3.3. New Product Launch & Enhancement
16.3.3.1. UL Solutions Rolls Out Medical Device Testing in Michigan, Helping the Industry Advance Safety of Healthcare Technology
16.3.3.2. Industries and IT Minister Launches Three Made-In-Telangana Medical Devices
16.3.4. Award, Recognition, & Expansion
16.3.4.1. Element Materials Technology Announces USD 8 Million Expansion in Cincinnati
16.3.4.2. New Microbiology and Chemistry Laboratory Opens to Accelerate Scientific Discovery
16.3.4.3. Grand Opening of New Bioanalytical Laboratory in Pudong, China
17. Competitive Portfolio
17.1. Key Company Profiles
17.1.1. 5D Health Protection Group Ltd.
17.1.2. Alliance Technologies, LLC
17.1.3. Almac Group Limited
17.1.4. AMETEK, Inc.
17.1.5. Applied Technical Services, LLC
17.1.6. Bioneeds India Pvt. Ltd.
17.1.7. Boston Analytical
17.1.8. Bureau Veritas S.A.
17.1.9. Cetecom Advanced GmbH
17.1.10. Charles River Laboratories, Inc.
17.1.11. Clark Testing
17.1.12. DDL, Inc.
17.1.13. DEKRA SE
17.1.14. Device Conformity and Testing, LLC
17.1.15. Element Materials Technology
17.1.16. Eurofins Scientific SE
17.1.17. ImpactQA
17.1.18. Innovatech Labs, LLC
17.1.19. Intertek Group PLC
17.1.20. iuvo BioScience, LLC
17.1.21. Laboratory Corporation of America Holdings
17.1.22. Maven Profcon Services LLP
17.1.23. Measur Oy
17.1.24. MED Institute Inc.
17.1.25. Medical Engineering Technologies
17.1.26. Nemko Group
17.1.27. North American Science Associates, LLC
17.1.28. Pace Analytical Services, LLC
17.1.29. Q Laboratories, Inc.
17.1.30. Qualitest Group
17.1.31. Qualizeal India LLP
17.1.32. Sanbor Medical Corporation
17.1.33. ScienceSoft Corporation
17.1.34. SGS S.A.
17.1.35. STEMart
17.1.36. Sterigenics U.S., LLC by Sotera Health company
17.1.37. STERIS PLC
17.1.38. TA Instruments by Waters Corporation
17.1.39. Tentamus Group GmbH
17.1.40. Test Labs Ltd.
17.1.41. The British Standards Institution
17.1.42. The Smithers Group Inc.
17.1.43. TÜV SÜD AG
17.1.44. UL LLC
17.1.45. WESTPAK, Inc.
17.2. Key Product Portfolio
18. Appendix
18.1. Discussion Guide
18.2. License & Pricing