Device Cybersecurity
Security-Conscious Development Mitigates Cyberattacks
From mobile phones and smart refrigerators to connected drug infusion pumps and late-model automobiles, hackers today enjoy an abundance of opportunity. Today the average cost of a single data breach is a staggering $9.48 million in the U.S. Hardening cybersecurity has never been more important. In fact, it is no longer a choice but a necessity to bake in device cybersecurity early in the development process to protect your organization’s customers and reputation, prevent serious legal issues, and achieve regulatory approval in the case of medical devices.
IoT Devices are More Vulnerable than Ever
In the U.S. last year, 1800+ data compromises, including data breaches, leakage and exposure, impacted more than 422 million people. Common threats to devices include weak authentication, insufficient data encryption, inadequate input validation, poorly configured access controls and insufficient testing and QA. To help you safeguard the software powering your connected devices, our cyber experts offer guidance, support and consultation in these areas:
Software Design & Threat Analysis
- Threat modeling
- Secure software coding standards
- Penetration testing and vulnerability scanning
- Secure configuration management
- User authentication and access control
- Regular security updates and patches
- Post-market plan
- Vulnerability management plan
- Security risk management plan
Platform-Specific Implementation
- OS updates and service packs
- Patch management
- Auditing and elimination or disablement of unused applications, services, ports and device drivers
- Software update, secure boot and data encryption (at rest and in transit)
- Operating system event logging
- Secure protocols, platforms and middleware solutions related to your device
- Key and certificate management
Navigating Regulatory Guidance & Standards
- FDA requirements/other standards feeding into FDA approval
- Protected health information (PHI) and HIPAA disclosure risk
- Achieving UL 2900 compliance as a precursor to regulatory approval
- Penetration testing -- planning and scope
- Documentation structure for approval
Blogs and Resources
EBOOK
Checklist for Cybersecurity Documentation
The FDA now mandates elevated levels of cybersecurity compliance. Streamline the process with our handy cybersecurity documentation checklist.
ARTICLE
Is Healthcare Ready to Pick Up the Pace?
In this Medical Design Briefs article, we explore the need for end-to-end protection to safeguard data and devices.
WEBINAR
Safeguard Devices from Cyber Threats
Regulated medical devices advancing through the approvals process have a high bar to clear to ensure cyber safety.
By partnering with ICS, you’ll benefit from accelerated time to market, decreased development inefficiencies, diminished development risk, and cost savings from enhanced usability.