Medical device cybersecurity quickstart
The quickstart is a short engagement with a simple goal: determine how ready your device is for regulatory scrutiny and what to do next. We review your device's design, modeled against actual threats, and evaluate technical implementation. The output is a prioritized set of areas to review, as well as a more robust understanding of how cybersecurity impacts safety and effectiveness of your specific device.
What you walk away with
Readiness feedback
An expert read on the device's cybersecurity posture, resilience against adversaries (penetration test readiness), and how it compares against regulatory guidance.
A prioritized gap list
What needs to change to address safety and effectiveness concerns from cybersecurity sources, as well as meet regulatory expectations.
A plan for what comes next
A recommended path through threat modeling, testing, and documentation that fits your device and your timeline.
Early enough to change the outcome
The quickstart fits teams early in the process, while there is still time to change course cheaply. Most clients engage ahead of a submission, a redesign, or their first penetration test. Nothing is wasted if deeper work follows: the quickstart output becomes the starting point for scoping and testing. Often information learned in the quickstart reduces cost and delay from cybersecurity issues just before submission.