Ilya Spivakov

Since 2025 I have supported 11 medical device cybersecurity engagements and 3 FDA submissions, two 510(k)s and one De Novo, with threat models, SBOMs, and penetration tests. Before that I spent 2 years maintaining the Varian Mobius 3D radiotherapy QA system and 10 years at an aerospace firm, including DO-178C software for an FAA-certified helicopter cockpit instrument. My deliverables follow the FDA premarket cybersecurity guidance, ANSI/AAMI SW96, and AAMI TIR57: threat models, security risk assessments, SBOMs, and penetration tests of web, mobile, and firmware attack surfaces.