Medical device chemical testing and scientific support for product development, regulatory submission, and production. Our team conduct chemical and physical analysis of medical devices materials and components.
Medical device testing, chemical analysis and scientific support enable the lifecycle for medical devices from clinical research, product development and regulatory submission through to production. Medical device companies will face multiple challenges to get safe and effective products to market including materials characterisation, contamination, stability, biocompatibility, problem-solving, failure resolution and manufacturing quality control. As medical device innovation continues to evolve to help meet patients’ requirements related to an ageing global population, increased life expectancy and chronic diseases, new technologies, materials and scientific support solutions will be critical to a successful product launch.
Our medical device testing experts provide scientific solutions for wound care, stents, cardiovascular implants, dermal fillers, orthopaedic implants, bone cement, biomaterials, catheters, in vitro diagnostics, combination products such as pre-filled syringes or inhaled drug products, and dental or surgical instruments. With over 30 years of experience in materials science, mechanical testing and chemical testing, our (GLP, GMP and ISO 17025) laboratories, and our scientists and engineers provide laboratory solutions, to drive insight into your products and processes. Through the considered application of analytical methods, robust data generation and experienced data interpretation, our approach and scientific rationale can accelerate your product development and enable your regulatory submission. Supporting production, Intertek’s medical device testing network reacts rapidly and efficiently to resolve manufacturing issues or in-field customer complaints.
Intertek does not provide consulting services for management systems certification. Any consulting activities provided by Intertek are separate and independent from certification activities.
Our significant expertise in bioanalysis studies allows us to support medical device companies working in the areas of preclinical and clinical development. Our support services include assay development for API’s, impurities, trace metals and degradants. We help determine residual solvents such as volatile organic compounds (VOCs) and organic volatile impurities (OVIs). We assess physical / chemical properties and have extensive capabilities for extractables and leachables testing supporting biocompatibility - including metals, polymer components and the evaluation of packaging materials.
Intertek’s extensive materials science laboratories offer analytical services for implantable medical devices and healthcare products. Typical analytical approaches to problem-solving include fracture and failure analysis, surface chemistry and adhesion, microstructure and mechanical property relationships, chemical imaging, and materials deformulation.
Our pharmaceutical laboratories (GLP/GMP) provide assay development and validation for pharmaceutical drug product-device interactions and material compatibility, the evaluation of product interactions with packaging materials, and the identification of trace impurities or degradation pathways. We have world-leading expertise in orally inhaled and nasal drug product development, formulation, stability and assessment of device performance related to delivered dose.
Our scientists and auditors extend your local problem-solving capability by having corrosion scientists, metallurgists, polymer scientists and pharmaceutical specialists on call. Intertek’s medical device network reacts exceptionally quickly and efficiently to manufacturing issues or in-field customer complaints. And being truly independent our clients find our patent infringement investigations and scientific legal advisory services highly informative and readily submissible to both customers and regulatory bodies alike.