Working through FDA's medical device cybersecurity requirements without the legalese. Updated guidance, RTA prevention, QMSR transitions — written for regulatory affairs leads and founders who need clarity, not page-count.
A researcher emails your team about a vulnerability in a device you already sell. Half the room wants to ship a quiet patch; the other half wants to call a lawyer. The question that actually decides what you owe the FDA is narrower than either instinct — and it has a name.
Read article →On February 2, 2026, the FDA replaced the 30-year-old Quality System Regulation with the new Quality Management System Regulation, incorporating ISO 13485:2016 by reference. The cybersecurity implications aren't obvious at first glance — but they're real, and they're already affecting how submissions get reviewed.
Read article →Since October 2023, FDA can refuse to accept a 510(k) on the cybersecurity documentation alone, before substantive review even begins. Most of those rejections are preventable. Here's what an RTA actually costs — and the five evidence patterns behind almost every one.
Read article →On February 3, 2026, the FDA quietly reissued its medical device cybersecurity guidance — 8 months after publishing the previous "final" version. Most manufacturers missed it. Here's what changed, what stayed the same, and what every cyber device maker needs to do about it.
Read article →Skip the reading. Take Omakyn's free 5-minute cybersecurity gap assessment and get a prioritized list of what's missing in your current documentation. No sales call. No signup.
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