Overview
Medical devices today are increasingly connected, software-driven, and integrated into hospital networks, making them vulnerable to cyber threats. In Indonesia, where digital health adoption is rapidly growing, securing medical devices is essential to ensuring patient safety, regulatory compliance, and continuity of healthcare operations.
Vulnerability Assessment (VA) and Penetration Testing (PT) are critical components in evaluating the cybersecurity posture of medical devices. These assessments help detect weaknesses before attackers exploit them and are key requirements in FDA 510(k) cybersecurity submissions.
Cyberintelsys, a CREST-accredited cybersecurity company, offers specialized VA/PT services tailored for FDA 510(k) medical device compliance. Our experts combine regulatory expertise with advanced testing techniques and internationally recognized best practices.
Why VA/PT Is Critical for FDA 510(k) Compliance
The FDA mandates that medical device manufacturers demonstrate strong cybersecurity controls as part of the FDA 510(k) premarket submission. Vulnerabilities can compromise device functionality, expose patient data, or cause patient harm.
Key reasons VA/PT is essential:
Detect vulnerabilities early: Identify software bugs, insecure configurations, and network flaws.
Regulatory alignment: Match FDA premarket cybersecurity documentation requirements.
Patient safety: Prevent cybersecurity breaches that affect life-critical devices.
Reputation protection: Avoid costly recalls, delays, and compliance penalties.
Healthcare regulators and enterprises in Indonesia increasingly prefer working with CREST-accredited firms like Cyberintelsys for trusted and standardized cybersecurity testing.
Cyberintelsys’ CREST-Accredited VA/PT Approach
As a CREST-certified cybersecurity provider, Cyberintelsys follows international standards aligned with FDA 510(k), IEC 81001-5-1, IEC 60601 Compliance Services, ISO, and NIST.
1. Scoping & Asset Identification
We begin with a detailed understanding of the device ecosystem:
Hardware, firmware, and software components.
Network protocols (Wi-Fi, Bluetooth, TCP/IP, medical IoMT protocols).
Mobile, desktop, web, or cloud applications.
Deliverable: Scope document and asset inventory.
2. Vulnerability Assessment (VA)
Automated scanning using advanced tools.
Manual analysis of firmware, configurations, and code.
Encryption and access-control assessment.
Third-party component and API validation.
Output: A VA report with severity scores, CVSS ratings, and remediation advice.
3. Penetration Testing (PT)
Network penetration tests (internal and external).
Device exploitation to demonstrate real-world impact.
Wireless testing for Bluetooth, Wi-Fi, IoT channels.
Mobile and cloud penetration testing.
Deliverable: Proof-of-concept exploit demonstrations (non-destructive).
4. Risk Analysis & Prioritization
All findings are analyzed based on likelihood, impact, and regulatory relevance.
5. Reporting & Compliance Documentation
FDA-ready documentation for cybersecurity submissions.
Risk matrices, remediation guidance, and evidence-based reporting.
Gap analysis for continuous cybersecurity enhancement.
6. Retesting & Validation
Cyberintelsys conducts retesting to ensure all vulnerabilities are resolved and device security is compliant.
Methodology Overview
Our VA/PT methodology aligns with CREST frameworks and FDA guidelines.
Key stages:
Reconnaissance
Threat modeling (STRIDE, MITRE ATT&CK)
Exploitation
Post-exploitation impact analysis
Reporting and compliance documentation
Benefits of Cyberintelsys VA/PT Services
1. Regulatory Assurance
Supports FDA 510(k) submissions with complete security evidence.
Faster approval with high-quality documentation.
2. Comprehensive Risk Mitigation
Prevent critical vulnerabilities before device deployment.
Reduce operational and reputational risks.
3. CREST-Certified Expertise
Testing conducted by CREST-accredited cybersecurity professionals.
Globally recognized methodologies.
4. Patient Safety & Trust
Enhances device integrity and user confidence.
5. Continuous Improvement
Supports secure SDLC integration.
Periodic assessments to stay ahead of emerging threats.
Industries & Device Types Supported
Cyberintelsys provides VA/PT for:
Diagnostic devices (MRI, CT, ultrasound)
Therapeutic devices (infusion pumps, ventilators)
Wearables and telemetry systems
Medical software, SaaS, APIs, and cloud platforms
Embedded IoMT devices
Why Cyberintelsys in Indonesia?
CREST-accredited cybersecurity company
Expertise in firmware, cloud, embedded systems, mobile apps, and IoT
Knowledgeable in FDA 510(k), IEC 60601, IEC 81001-5-1, ISO, MAS TRM, and NIST frameworks
Audit-ready and regulatory-friendly reporting
Local support tailored to Indonesia’s healthcare ecosystem
Conclusion
For medical device manufacturers in Indonesia, FDA 510(k) cybersecurity compliance is essential for patient safety, regulatory approval, and market success.
Cyberintelsys delivers CREST-accredited VA/PT services that ensure:
Comprehensive vulnerability detection
FDA-aligned cybersecurity documentation
Improved device security and safety
Faster and more successful regulatory submissions
Partner with Cyberintelsys to secure your medical devices and meet global cybersecurity standards.
