Medical Device Testing
Medical Device Testing Across the Entire Product Lifecycle
Testing needs evolve as medical devices and drug device combination products progress from early development to commercial production and ongoing lifecycle management. Our global team of experienced scientists works across microbiology, analytical chemistry, physical and functional testing, and biocompatibility to deliver coordinated testing programmes. Decades of experience supporting hundreds of device programmes worldwide help teams move from R&D to commercialisation with confidence and regulator-ready data.
Device testing services across the device lifecycle
Analytical Chemistry
Chemical characterisation, extractables and leachables, impurities, and materials analysis.
Microbiology & Sterility
Bioburden, sterility, Pyrogen, and environmental monitoring.
Physical & Packaging Testing
Device performance, mechanical integrity, packaging validation, and distribution testing.
Biocompatibility & Toxicology
ISO 10993 testing, biological evaluation, and toxicological risk assessment.
Consultancy & Scientific Support
Testing strategy, biological evaluation plans and reports, and submission support.
Supporting every stage of the medical device lifecycle
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Research & Early Development
Material understanding, feasibility testing, and early performance insights.
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Design Verification
Testing to confirm devices meet design inputs and functional requirements.
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Design Validation
Evidence generation to demonstrate safe and effective use.
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Regulatory Submission & Approval
Testing data to support global regulatory submissions and market approval.
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Commercial Production & Post-Market Support
Ongoing testing, change management, and lifecycle compliance.
Experienced across a wide range of medical device and combination products
Injection, Drug Delivery & Inhalation Devices
Pre-filled syringes, auto-injectors, inhalers and OINDPs, on-body delivery systems, infusion devices, and safety syringes.
Surgical, Hospital & Wearable Devices
Catheters, anaesthesia and respiratory devices, surgical instruments, connected and wearable technologies.
Implantable, Ophthalmic & Specialised Devices
Orthopaedics, cardiovascular devices, ophthalmic products, dental devices, and robotic surgery systems.
Ready to discuss your medical device testing requirements?
Whether you are at an early development stage or preparing for regulatory submission, experienced scientific teams are ready to help you define the right testing pathway and move forward with confidence.
Laboratories near you, supporting global product success
With accredited laboratories in the UK, EU and US, we support pharmaceutical, medical device and combination product manufacturers worldwide. Local support combined with global quality, delivered by teams who understand your regulatory requirements.
Our Clients’ Experiences