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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.

Why take a threat modeling course?

Regulators, including the U.S. Food & Drug Administration (FDA) and the European Union under MDR/IVDR, are embracing threat modeling as a recommended best practice to assure the appropriate reduction of cyber risks of medical devices.

safety risks

Threat modeling identifies & helps reduce potential security issues across risk types for makers and users; including patient safety risks.

r & d

R&D teams need to incorporate security into their continuous design and engineering processes.

threats identification

Ensures that your team has the ability to identify threats and iterate on existing threat models that are generated.

development lifecycle

Allows security to be a part of the medical device development lifecycle.

Threat Modeling Course Syllabus

Whether you want a virtual 3 hour self-driven course or in-person training with our world-class threat modelers, find confidence in your security strategy and related mitigations.

This course will teach you how to:

Create, maintain, and update a threat model for a medical device
Understand how to use and communicate the threat modeling outputs for engineering and regulatory submissions
Each stage of the threat modeling process will use a fictional medical device. We’ll also link each aspect of the training back to regulatory requirements so you can see how this will directly impact your submission materials.


At the end of the course, you'll build your own FDA-ready  threat model using our templates, receiving personalized feedback, and then you'll be ready to start threat modeling your own devices!

Our threat modeling professors

Our team of former FDA analysts and medical device experts provides the best-qualified, credentialed, and experienced product security benefit-risk assessment in the world. Don’t go at this problem alone.

Naomi Schwartz

Naomi Schwartz

VP, Services
Seth Carmody

Seth Carmody

VP, Regulatory Strategy
William Fenstermaker

William Fenstermaker

VP of DevOps
AJ Reiter

AJ Reiter

Director, Strategy and Organizational Transformation

Ready to take the Threat

Modeling course?

Get your secure medical devices to market on or even ahead of schedule,
with peace of mind.

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