https://razortooth.biz/categories/medical/ Recent content in Medical on Razortooth Communications, LLC Hugo en-us https://razortooth.biz/services/fda-medical-device-cybersecurity/ Mon, 01 Jan 0001 00:00:00 +0000 https://razortooth.biz/services/fda-medical-device-cybersecurity/ <h2 id="who-it-is-for">Who it is for</h2> <p>Device makers preparing a premarket submission who would rather find the holes now than have a reviewer find them later.</p> <h2 id="what-you-get">What you get</h2> <ul> <li>A threat model of the device, its app, its firmware, and its cloud middleware.</li> <li>A findings report with concrete fixes, prioritized by exploitability and patient impact.</li> <li>A hardened design you can hand to your filing consultants with confidence, before you spend the $80K on the filing itself.</li> </ul> <h2 id="how-it-runs">How it runs</h2> <p>Duration: 4 to 8 weeks. We work inside your quality system and leave the documentation in a form your regulatory team can reuse.</p>