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| Intertek ASG Laboratory, Manchester, UK
Analytical Services for Medical Devices
Intertek ASG provides high quality, customer-focused analytical support to developers and manufacturers of healthcare related products through project-managed analysis, consultancy and problem-solving services. The laboratory offers an extensive range of instrumentation and expertise for chemical and physical characterisation. GLP certification and GMP/cGMP compliance allows Intertek ASG data to be used in regulatory submissions. Specific capabilities to support the research and development of medical devices include:
- Protocols to meet the extractables and 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 characterisation of materials
- ISO/TS 10993-19 - Physico-chemical, morphological and topographical characterisation 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 characterisation studies to support medical device R&D including:
- Profiling migration of potential leachables towards surface
- Characterisation of functionalised surfaces
- Studies of protein binding to functionalised surfaces
In addition to the services provided by Intertek ASG, 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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