Incident Response Readiness Review

A cybersecurity incident demands more than just a plan—it requires a prepared and confident team.

Our Incident Response Readiness Review moves you from theoretical readiness to decisive action, ensuring your organization can respond swiftly and effectively when it matters most.

Medcrypt logo on gradient pole
medcrypt logo

Actionable roadmaps

Medical device cybersecurity is a hard problem to solve. Our Services team provides actionable roadmaps to facilitate product development, quality, and security frameworks to meet your pre- and post-market needs. No matter where you are in your process, we enhance your processes and agile methodologies to get to market, while optimizing your resources.

Need cybersecurity strategy help

FDA cybersecurity readiness

Optimize your path to FDA cybersecurity readiness. We partner with you to ensure your devices can achieve the highest level of regulatory review, as well as develop cybersecurity programs that scale with you. Get your secure medical devices to market on or even ahead of schedule, with peace of mind.

FDA hold letter response

Get immediate guidance to navigate your response process effectively.

Threat modeling

Ensure your software ecosystem is protected and incorporate continuous security improvements into your design and engineering processes. We do a deep-dive investigation into your architecture, design, requirements, and implementation to create threat models that review current state, refine trust boundaries, identify requirements, and propose remediations, ensuring that your hardware, firmware, software, network communication, and data handling components to ensure you are protected now and in the future.

Cryptography design and review

We assess your PKI and certificate management practices, perform gap analysis with industry best practices and regulatory guidance, and develop realistic and actionable mitigation strategies for medical devices.

How Medcrypt Helps:

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.

Our proven track record

Every customer who needed help navigating cybersecurity documentation requirements for the FDA has had a 100% success rate.

Now, we’re offering a 100% guarantee for new customers: If you follow our guidance and your product meets cybersecurity expectations, we’ll support you through all FDA feedback - until your cybersecurity documentation is accepted.

Naomi Schwartz

Naomi Schwartz

VP of Services
Seth Carmody

Seth Carmody

VP of Regulatory Strategy
AJ Reiter

AJ Reiter

Director of Strategy and Organizational Transformation
Nick Atwell

Nick Atwell

Senior Manager of Cybersecurity

Resources

Expert content to help you through your regulatory submission journey.