Daily intelligence for device makers
A daily briefing on FDA, EU MDR, ISO, and global regulatory developments — written for the professionals who build devices, not for the consultants who write about them.
CDRH finalizes AI/ML SaMD modification guidance. The long-awaited update clarifies when algorithm changes require a new 510(k). Bottom line: performance-only updates with no changed intended use probably don't need submission. Changes to inputs or intended use — that's a different story. Read the full guidance before you ship your next update.
MDCG 2026-4 clarifies post-market surveillance timelines. Notified bodies are now expecting annual PMS reports for Class IIa+ devices, even when no incidents occurred. If your PMS plan still says "as needed," it's time for a rewrite.
QMSR transition clock: 16 months remaining. FDA's alignment with ISO 13485:2016 becomes effective February 2027. Companies still running dual QSR/ISO systems need to start their gap assessment now — integration takes time you probably don't have.
Structured, factual, written with a point of view. Not a press release rewrite.
Recalls and warning letters don't happen at random. We track the enforcement signals and tell you when the pattern suggests a coming crackdown in your category.
Every briefing fits the time between your coffee and your first meeting. Concise takes, clear hierarchy, no padding. If it can be said in 300 words, we won't use 800.
Every claim links to a CFR section, ISO clause, guidance document, or openFDA entry. We tell you what we know and where to verify it. No vague references.
Regulations are written by lawyers for lawyers. We translate what changed, why it matters, and what you need to do about it — before your coffee gets cold.
510(k), 513(g), PMA, De Novo, UDI, QMSR, enforcement actions, recall database, guidance documents
MDCG guidance, notified body capacity, EUDAMED registration, CE marking timeline changes
ISO 13485, 14971, 62304, 60601 series, new and revised standards with regulatory relevance
UKCA marking, UK MDR 2002 post-Brexit updates, MHRA guidance and consultations
MDSAP requirements, Health Canada IVDD/MDD transitions, Class II–IV license updates
Japan's Pharmaceutical and Medical Device Agency, Australia's Therapeutic Goods Administration
The regulatory professionals who read this are the same people who write FDA 483 responses, sit in on CE audits, and sign their names to regulatory submissions. If we get something wrong, they'll know — and they'll tell their colleagues.
That's not a risk. That's the point. Our quality bar is defined by the most demanding audience in the industry.
"Regulatory intelligence shouldn't require a compliance degree to decode."
The people who build medical devices — who design them, validate them, manufacture them, and stand behind them — deserve better than government press releases rewritten by content algorithms. They deserve a briefing written by people who've been in the room. Who know the difference between a 510(k) and a De Novo without having to look it up. Who will tell you when something actually matters and when it's just noise.
That's what we're building. Every morning. No exceptions.