FDA premarket 510k medical device security verification

When selling medical devices in North America, it is mandatory to conduct information security assessments for the devices as required by local authorities (FDA).

One of the inspection services provided by our company, HERMAS, mandates that when selling medical devices in North America, local authorities (FDA) require the implementation of information security assessments for the devices. As of now (September 2021), we will conduct inspections of your products at our inspection laboratory in Taiwan, which complies with international standards (ISO17025), or at our inspection laboratory in our Tokyo office. The report will be provided in English for submission to the FDA. Additionally, by utilizing the know-how we have accumulated so far, we have achieved cost and time reductions, which we pass directly on to our customers. *Japanese reports can also be quoted separately.

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