Cyber Security & Digital Vulnerability Assessment

Under the new regulations, cyber devices, which encompass software within a medical device, are required to adhere to specific guidelines. Our team of experts can assist you in meeting these requirements effectively. Here’s what our cyber security services entail:

Cyber Security Lifecycle Management:

We will help you develop a robust plan to monitor, identify, and address cybersecurity vulnerabilities and exploits that may arise after the device has been released to the market. Our goal is to ensure a reasonable timeframe for response and resolution, including coordinated vulnerability disclosure procedures.

Cyber Security Design and Development:

Our experienced professionals will work closely with your team to establish processes and procedures that guarantee the reasonable assurance of cybersecure devices and related systems. We emphasize the importance of making post-market updates and patches available to ensure ongoing security.

Software Bill of Materials (SBOM):

We will assist you in generating a comprehensive software bill of materials that includes all commercial, open-source, and off-the-shelf software components used in your medical devices. This documentation is crucial for transparency and enables effective tracking of potential vulnerabilities.

Expertise and Compliance:

Our team has a deep understanding of the FDA’s cyber security requirements and regulatory landscape. We stay up-to-date with the latest guidelines to ensure that our clients remain compliant at all times.

Industry Knowledge:

We recognize the growing significance of cyber security threats in the healthcare sector. With the increasing use of connected devices and electronic exchange of medical information, the risks have become more severe and impactful. Our services are tailored to address these evolving challenges.

Collaborative Approach:

We value collaboration and will work closely with your organization to develop customized solutions that align with your unique requirements. Your input and feedback are integral to the success of our cyber security services.

Secure Product Development Framework (SPDF):

We strongly recommend implementing an SPDF, as it encompasses all aspects of a product’s lifecycle and aids in meeting Quality System Regulation (QSR) requirements. Our team can guide you in integrating an SPDF into your existing processes, minimizing vulnerabilities and uncontrolled risks.

Metrics and Assessments:

We understand the importance of measuring cyber security effectiveness. Our services include assessing vulnerabilities and tracking key metrics, such as defect density, time from vulnerability identification to patching, and time from patch availability to implementation in the field.

As a trusted leader in cyber security services for the medical device industry, Megalab is dedicated to safeguarding patient safety and ensuring regulatory compliance. With our expertise, collaborative approach, and emphasis on SPDF implementation, we can help you navigate the evolving cyber security landscape effectively.

Standards Coverage:

• IEC TR 60601-4-5 Medical device Cyber security
• IEC 81001-5-1 Security – Activities in the product life cycle
• ISO 62443-3-2 Security for industrial automation
• Pre-Market Vulnerability of Cyber security
• Post-Market Risk Management
• Cyber security for networked medical devices
• Section 524B(a) of the FD&C Act 21 CFR 820.100
• ISO 14971
• IEEE 2621

Contact us today to learn more about our comprehensive cyber security services and how we can assist your organization in meeting the regulatory cybersecurity requirements for your device. Together, let’s build a more secure future – contact us to start now!