Originally published August 2025.
Welcome to Insider issue #40.
Also, hello to the 210 life science professionals who joined us last month. If you haven’t already upgraded to a paid subscription to unlock our in-depth analysis issues like this one, you can do so here.
This month marks a significant milestone for regulatory oversight: what began as pandemic necessity has become permanent practice.
The FDA has formalized Remote Regulatory Assessments as a standard tool, and companies that don’t adapt will find themselves perpetually unprepared. Meanwhile, medical device cybersecurity has moved from “nice to have” to “must submit”—the June 2025 guidance makes clear that your 510(k) or PMA now requires a comprehensive cybersecurity package.
Our warning letter analysis this month is a cautionary tale about the difference between having a quality department and having an actual quality program. The findings at Dynamic Blending Specialists are, frankly, shocking—and entirely preventable.
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