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FDA,MDR&IVDR Cybersecurity Services

China

Cybersecurity compliance services enabling medical device manufacturers to meet FDA, MDR, and IVDR regulatory requirements. Provides risk assessment, vulnerability management, and security documentation to support device authorization and post-market surveillance obligations.

Manufactured by

Seczone Co., Ltd.

China

Seczone provides one-stop cybersecurity services for medical device market access including FDA, MDR, and IVDR registration. Services include cybersecurity consulting, testing (source code analysis, SCA, vulnerability scanning, penetration testing, fuzz testing, SBOM), and documentation (risk management, threat modeling, cybersecurity risk assessment, and management plans).

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