The FDA's premarket cybersecurity guidance (Section 524B of the FD&C Act, effective October 2023) requires medical device manufacturers to submit cybersecurity documentation as part of their premarket submissions.
Our FDA cybersecurity practice helps medical device manufacturers, digital health companies, and IVD developers build and document the cybersecurity controls the FDA expects.
We bring a compliance-first approach grounded in NIST CSF 2.0, IEC 62443, AAMI TIR57, and the FDA's own guidance documents.
Frameworks: FDA Premarket Cybersecurity Guidance, NIST CSF 2.0, IEC 62443, AAMI TIR57, HIPAA, UL 2900
適用對象
- Medical device manufacturers preparing premarket submissions requiring cybersecurity documentation
- Digital health and SaMD companies building connected health platforms
- In vitro diagnostic (IVD) manufacturers with networked or cloud-connected systems
- Contract manufacturers and OEMs supplying components for connected medical devices
- Medical device companies that received FDA deficiency letters citing inadequate cybersecurity documentation
您將獲得
- Threat modeling and cybersecurity risk assessment per AAMI TIR57 and FDA guidance
- Software Bill of Materials (SBOM) generation in SPDX or CycloneDX format
- Cybersecurity design documentation for premarket submissions
- Vulnerability assessment and penetration testing of device firmware, APIs, and cloud interfaces
- Patch and update management plan documentation
- Coordinated vulnerability disclosure (CVD) policy and process
- Postmarket cybersecurity surveillance program design
- Gap assessment against FDA premarket cybersecurity guidance and NIST CSF 2.0
- Remediation support for FDA deficiency letters related to cybersecurity
常見問題
透過滲透測試強化FDA 網路安全合規性
以真實攻擊模擬驗證您的安全控制措施。我們的OSCP認證從業者在外部網路、內部網路、Web應用程式、行動應用程式、API、IoT、無線網路和Red Team八個領域執行手動、方法論導向的測試。
瞭解滲透測試