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| Intertek Pharmaceutical Services > Medical Devices |
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Analytical Services for Medical Devices |
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Intertek provides high quality, customer-focused analytical support to developers and manufacturers of healthcare related products through project-managed analysis, consultancy and problem-solving services. Intertek offers an extensive range of instrumentation and expertise for chemical and physical characterization. GLP certification and cGMP compliance allows Intertek data to be used in regulatory submissions.
Specific capabilities to support the research and development of medical devices include:
- Protocols to meet the extractables / leachables requirements of directive 93/42/EEC, Annex 1 Clause 7, and chemical testing according to ISO 10993 standards, including:
- ISO 10993-18:2005 - Chemical characterization of materials
- ISO/TS 10993-19 - Physico-chemical, morphological and topographical characterization of materials, when published
- Extractables / leachables studies of device materials
of construction (e.g. polymers, metals)
- Clinical sample handling facility allowing analysis of samples from in vivo investigations (e.g. heavy metals in plasma from materials used in arthritic joint replacements)
- Determination of release characteristics in drug / device combinations (to support R&D, regulatory submissions or product QC)
- Raw materials testing
- Advanced characterization studies to support medical device R&D including:
- Profiling migration of potential leachables towards surface
- Characterization of functionalised surfaces
- Studies of protein binding to functionalized surfaces
In addition to the services provided by Intertek Pharmaceutical Services, the Intertek Group has broader medical devices capabilities through the ETL Semko Division including:
- Extensive expertise in the electrical testing of medical
devices
- Notified Body and Competent Body status in the European Union
- Accredited by the FDA to conduct FDA 510(k) premarket notifications under section 510(k) of the Federal Food, Drug and Cosmetic Act.
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