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Medical Devices
We provide testing for Europe and for ETL listing for medical electrical devices, focusing on MRI, CT equipment and desktop ophthalmic examination equipment. In addition to that, we provide support for 510(k), working with our colleagues at Intertek ETL SEMKO in North America who are accredited by the FDA as a third-party reviewer of medical device premarket notifications under Section 510(k) of the Federal Food, Drug and Cosmetic Act. We will work with you from start to finish - we evaluate your 510(k) pre-market notification file, submit it to the FDA's Center for Devices on Radiological Health (CDRH), and manage your product's clearance through the Office for Device Evaluation (ODE) and its Market Clearance Letter.
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