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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basic information
<Test Plan (1+2)> 1. Basic Fees - FW (Firmware) Scan - Project Management Costs 2. Various Desired Test Items - Network Test - Bluetooth Test - Wireless Communication Test - Web Interface Test - Penetration Test for Cloud Services - Stress Test For other matters, such as conducting fuzz testing for robustness testing, please consult us individually.
Price range
P4
Delivery Time
Applications/Examples of results
The diagnostic items are broadly divided into seven categories, with detailed subdivisions for mandatory and recommended items, and our company conducts verification of all or some of them. We have already received requests from manufacturers of diabetes testing devices and CR devices and have a track record of conducting verifications.
Company information
Our company is a world-class manufacturer in the field of information security solutions for network products, established in 2014. In addition to our ISO17025 compliant verification lab, we have developed our own AI automated information security assessment system and boast numerous patents and awards. We support our customers, including government agencies, IoT/IIoT providers, financial institutions, and telecommunications companies, in obtaining certifications related to information security to prevent potential information security threats and vulnerabilities, ensuring the safety of confidential information and products.