Medical Device Materials Testing

Medical device materials testing is a core need to enable the development and production of medical materials and medical products and to ensure that materials are safe, durable, and perform as intended. 
As devices become more advanced and incorporate new materials, coatings, and manufacturing methods, the need for robust materials evaluation has never been greater. Testing helps verify that components can withstand mechanical stresses such as strength, compression, and fatigue. During medical device material selection, it confirms that the chemical composition is well understood, particularly when identifying potential leachable substances from medical plastic materials that could migrate into the patient.

Despite its critical importance, medical device materials testing presents significant challenges for manufacturers.  Medical device materials and components must meet stringent global standards, such as ISO 10993-Part 18, and testing requirements can evolve as materials sourcing or processes change or new regulatory expectations are published. 

Our Medical Devices Materials Testing Expertise
Intertek offers comprehensive medical device materials testing services aimed at supporting the development, production, and performance of medical devices, polymers, ceramics, polymer composites in medical applications, multi-layer systems, and metals. 

Our team of experts specialise in analysing materials and components, providing valuable insights into their composition, physical and mechanical properties, microbiological quality, and more. From R&D analytical support to material characterisation and stability testing, we equip clients with the knowledge needed to optimise their products. With advanced instrumentation and a commitment to quality, our scientists deliver robust solutions that address the evolving challenges of the medical device industry.

Why Work with the Intertek Medical Materials Team?
End-to-end lifecycle experience: We support R&D, formulation, processing, QA, recycling, toxicological & safety assessments and product failure investigations
Trusted laboratory testing: Includes ISO 17025, UKAS, GLP/GMP, and A2LA laboratories, delivering reliable results by expert chemists and engineers. 
Decades of expertise: Over 40 years of expertise supporting global medical materials and medical device innovators and manufacturers. 
Supply chain support: Strengthening your supply chain through materials evaluation, supplier and materials mapping, risk assessment, and sourcing strategies via SupplyTek.
Future-proof operations: Supporting your business growth with regulatory compliance and quality auditing. 

Key Testing Areas
Chemical testing: We identify and characterise the chemical composition of the materials and substances used to make the device. Testing is aligned with ISO 10993-18 chemical characterisation, and includes analysis for leachables substances that could migrate from the device into the patient. We use techniques such as mass spectrometry and spectroscopy to generate robust, insightful data.
Mechanical and Physical Testing: Using a wide breadth of mechanical and physical tests, we evaluate a material's durability and strength. Our capabilities include testing for tensile strength, elasticity, and fatigue resistance to help assess performance and suitability.
Cleaning Validation Analysis and Compatibility testing: We evaluate materials for their compatibility with cleaning agents, disinfectants, and sterilisation methods used during production (cleaning validation analysis) and in use. 
Medical Materials Surface and Coatings Testing: We test the suitability and performance of surfaces, coatings and adhesives used in medical devices. This helps to verify that performance is optimal and remains stable throughout repeated use or exposure. We also provide metallurgy, corrosion testing including chemical resistance.
Microbiological Testing: Working to ISO 846 and other established test methods, we assess conditions to assess the impact of microorganisms on plastic surfaces.

Complete Lifecycle Support -Testing to Support Medical Device Innovation and Production

R&D Analytical Support:  

• Mechanical testing of materials in polymers, devices and packaging
• Understanding rheological properties, molecular weight information and performance
• Materials integrity and deformulation
• Microstructure – product property relationships, phase distribution and chemical imaging
• Surface morphology and adhesion studies
• Testing for IEC 60601 material considerations

Stability and Medical Device Testing:

• Stability and storage
• Extractables and leachables
• Chemical characterisation (ISO 10993 part 18)

Production Support: 

• ASTM and ISO testing for raw material validation
• Material characterisation and QC analysis
• Batch-to-batch consistency testing
• Quick turnaround programs for data generation across chemical, mechanical, physical, electrical, optical, rheology, weathering, thermal, and flammability (ASTM, ISO)
• Trace metals, degradants, contamination, residual solvents, and volatile organic compounds (VOCs) in polymers and plastics 

Product Failure Investigations:

• Fracture and failure investigation of materials and contamination analysis
• Microstructure and mechanical property relationships
• Connecting polymer chemistry with device performance
• Surface chemistry and adhesion
• Material deformulation
• Microscopy of medical devices

Your Medical Device Materials Testing Partner
We use our 30 years of materials science, processing knowledge, and physical testing experience to design test programs that help achieve optimal performance, safety, and sustainability for your packaging materials.
At Intertek, we are committed to providing comprehensive scientific support tailored to the unique needs of the medical device industry. Our expert team and advanced capabilities ensure that your products meet the highest standards of safety and performance. Partner with us today to enhance your innovation and stay ahead in this competitive market.