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
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.
Get immediate guidance to navigate your response process effectively.
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.
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.
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.
Threat modeling identifies & helps reduce potential security issues across risk types for makers and users; including patient safety risks.
R&D teams need to incorporate security into their continuous design and engineering processes.
Ensures that your team has the ability to identify threats and iterate on existing threat models that are generated.
Allows security to be a part of the medical device development lifecycle.
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.
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 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.
Get your secure medical devices to market on or even ahead of schedule, with peace of mind.