Leadership

    Michelle Hughes

    Director of Operations

    Michelle Hughes is the Director of Operations at Blue Goat Cyber, where she drives complex MedTech cybersecurity engagements from kickoff through FDA clearance. She coordinates technical, QA, and regulatory workstreams so threat models, SBOMs, penetration tests, and submission packages move in lockstep with the manufacturer's product and regulatory calendar.

    Michelle's focus is a predictable delivery rhythm: senior practitioners on every meeting, submission-grade artifacts formatted to eSTAR structure, and clear checkpoints that keep engineering, quality, and regulatory teams aligned without surprises.

    Ready when you are

    Get FDA cleared without the cybersecurity headaches.

    30-minute strategy session. No cost, no commitment - just answers from people who've shipped 275+ devices supported.