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.
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 the FDA began enforcing SBOM requirements in October 2023, roughly one in seven 510(k) submissions hits a Refuse to Accept decision before substantive review even begins. Most are preventable. Here's what an RTA actually costs — and the five patterns that explain 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.
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