Imagine a scenario where a zero-day vulnerability is actively being exploited in one of your on-market products. Clients are feeling the impact and want help. The Incident Response Team is receiving a flood of calls, and internal teams are scrambling to determine what data was accessed, but no one can agree on which logs to review or who owns the impacted system. Would your team know the steps to take to manage the incident? When a security incident hits, how confident are you that your team can act swiftly, decisively, and in sync?

A delayed or disorganized response to a cybersecurity incident can lead to severe consequences, including patient safety risks, intense regulatory scrutiny, and lasting reputational damage. Your organization needs more than just a playbook; it needs a team that is ready to execute.

That’s why we’re excited to introduce our Incident Response Readiness Review.

What is the Incident Response Readiness Review?

Our Incident Response Readiness Review is a fixed-fee engagement designed to evaluate and significantly strengthen your existing incident response capabilities. We engage cross-functional stakeholders from R&D, QA, Customer Support, Postmarket Surveillance, Product Security, Legal, and Communications to conduct a targeted review of your incident response process. The goal is to identify gaps that could delay your response, affect your reputation, or increase regulatory exposure, and to Align your playbook with industry best practices such as NIST SP 800–61r3.

We begin by assessing your current incident response plan. We’ll meticulously review your existing documentation against industry best practices to pinpoint any gaps or areas for improvement. Simultaneously, we’ll engage key stakeholders across engineering, quality, compliance, support, and post-market functions. Their real-world insights will help us uncover practical deficiencies in your processes that could hinder your response or increase your risk.

Once these gaps are understood and remediations are in place, we facilitate a tailored, high-impact table-top simulation to validate your updated process and build organizational confidence. This mock incident is grounded in realistic scenarios specific to your product(s) and threat profile, helping teams clarify responsibilities, improve coordination, and prepare for the real thing.

The result? A clearer, stronger, and more actionable incident response process that significantly improves your organization’s readiness and reduces risk.

What Sets Us Apart?

Our Incident Response Readiness Review offers several key differentiators:

• Regulatory Integration: We target all requirements from Section 524B of the FD&C Act, following the Premarket and Postmarket Cybersecurity Guidance documents, to ensure your policies align seamlessly with regulatory expectations.
• Comprehensive Support: Beyond simulated incidents, we help you plan and create robust policies and procedures, and offer expert input to develop or improve your incident response playbook, including leveraging standards as appropriate, given your existing quality management system (QMS).
• Targeted Improvements: Our exercises identify precise gaps in your processes and policies, driving targeted improvements to strengthen your security framework to better protect your organization’s clients, reputation, and product lines.
• Funding Support: By highlighting critical areas for enhancement, our exercises help your security team secure necessary funding from your executive team to ensure cybersecurity investment for your products and your processes.
• Realistic Scenarios: We craft tailored exercises that mimic real cybersecurity incidents based on your product portfolio, providing hands-on experience to prepare your team for actual breaches.

These differentiators ensure our review not only prepares your organization for cybersecurity threats but also significantly enhances your overall security posture and supports continuous improvement.

Are you ready to move beyond theoretical readiness and ensure your team is truly prepared for the next cybersecurity incident? Contact us today to learn more about our Incident Response Readiness Review.