FDA Medical Device 510(k)
eSTAR Cyber Security Consulting
We provide comprehensive cybersecurity consulting services for FDA eSTAR submissions.
We provide expert support for all eSTAR Cyber Security items, including Risk Management (Report, Threat Modeling, Risk Assessment, SBOM), Metrics, and Cybersecurity Testing, to ensure successful FDA approval for medical device manufacturers.
FDA Medical Device 510(K) eSTAR Cyber Security Consulting
Based on years of experience in medical device vulnerability analysis and an understanding of FDA regulations, we efficiently support manufacturers' eSTAR preparation process to increase the likelihood of FDA approval.
FDA Medical Device 510(k)
Due to stricter regulations by government agencies and the increasing network connectivity of medical devices, the need for ESTAR cybersecurity testing is becoming increasingly important. The FDA places great importance on the cybersecurity of medical devices and requires the submission of cybersecurity-related documents, including the following items, when submitting for ESTAR.
Medical device cybersecurity is a rapidly changing field that requires an in-depth understanding of the latest technologies and regulatory trends. Based on their extensive experience and expertise, expert consultants support manufacturers in effectively responding to cybersecurity requirements and successfully obtaining 510(k) approval.
Enhanced regulatory compliance
FDA는 의료기기의 안전성과 유효성 확보뿐만 아니라 사이버 보안까지 중요한 평가 요소로 간주하고 있습니다. eSTAR 양식은 사이버 보안 관련 질문들을 포함하고 있으며, 제조사는 이에 대한 상세한 답변과 증거를 제출해야 합니다
Efficient eSTAR writing
eSTAR는 전자 형식의 제출 템플릿으로, 모든 필수 정보를 체계적으로 포함하도록 설계되었습니다. 사이버 보안 분야는 기술적인 전문성이 요구되므로, 경험 있는 컨설턴트의 도움을 받아 정확하고 누락 없는 정보를 제공하여 심사 지연이나 거절의 위험을 줄일 수 있습니다.
Cybersecurity Risk Management
의료기기는 환자의 건강과 직결될 수 있으므로 사이버 공격에 취약할 경우 심각한 결과를 초래할 수 있습니다. 컨설턴트는 위험 분석, 위협 모델링, 취약점 테스트 등을 통해 잠재적인 사이버 보안 위협을 식별하고, 이를 완화하기 위한 적절한 보안 통제 방안을 제시합니다.
Security design and development
It is important to implement designs that consider cybersecurity from the early stages of medical device development. Consultants support the establishment of a Secure Product Development Framework (SPDF) and enhance product security through the implementation and testing of security features.
Software Material of Materials (SBOM) and Vulnerability Management
The FDA requires the submission of a Software Statometer (SBOM), a list of software components used in medical devices, and places significant importance on management plans for known vulnerabilities. Consultants support the creation and management of SBOMs, as well as vulnerability analysis and the establishment of response plans.
Establishment of post-incident monitoring and response plans
Cyber security threats can persist even after medical devices are launched on the market. Consultants support the development of plans to monitor, identify, and remediate post-launch cyber security vulnerabilities, and to appropriately communicate relevant information to stakeholders.
eSTSR Cybersecurity Verification Items for FDA Certification
Risk model
의료기기가 직면할 수 있는 잠재적 보안 위협을 체계적으로 식별하고 분석하는 방법론
report
의료기기의 사이버보안 위험 평가, 위협모델링, 보안통제 구현 등 전체 위험관리 활동의 결과를 문서화한 종합 적인 자료
Cybersecurity Risk Assessment
의료기기가 직면할 수 있는 잠재적 보안 위협을 체계적으로 식별하고 분석하는 방법론
SBOM and related information
SBOM containing open source and third-party components used in medical devices and license information
Stability and security assessment regarding software support levels, information documentation, and vulnerabilities
Assessment of abnormal signs
사이버보안 영향에 대한 해결되지 않은 이상 징후에 대한 평가
Cybersecurity Metrics
Cybersecurity metric monitoring data (indicators for quantitatively measuring the security status and effectiveness of medical devices)
Cybersecurity Control
Protective measures designed for managing security risks of medical devices
(Access/Control/Authentication/Password/Resilience/Recovery/Logging/Updates, etc.)
Architecture View
System architecture including Global System, Multi-Patient Harm, Updability, and Security Use Cases
Cybersecurity test
DHF, Threat Mitigation Document, Vulnerability Testing, Penetration Testing
Cybersecurity Labeling
Cybersecurity information labeling document/information among the labeling of submitted medical devices
Cybersecurity Management Plan
Cybersecurity management plan document for identifying and communicating vulnerabilities discovered since release
서울본사
서울특별시 송파구 법원로 8길 9 청림타워 10층
부산지사
부산광역시 해운대구 우2동 센텀중앙로 55 8층
세종지사
세종특별자치시 조치원읍 군청로 95 세종테크노파크 2층
연락처
서비스
사이버보안 교육/훈련 (온/오프라인)
OT/IoT 취약점 점검 (Red Team 서비스)
FDA eSTAR 인증 컨설팅 (의료기기 인증)
산업제어시스템 컨설팅 (IEC 62443)
가상자산 조사/분석 (체이널리시스 총판)
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