Learn what FDA Cybersecurity Guidance means for medical device and life sciences companies, including 524B, risk-based validation, secure design, and ongoing cybersecurity readiness.
Learn how to improve EU MDR/IVDR EUDAMED readiness with practical steps for data, registration, governance, and global medical device regulatory alignment.
Most life sciences companies cannot describe what data they have, where it lives, or what can be done with it. This article presents the two-horizon framework for data classification — building from AI-safe search to full agentic AI readiness.
A cyberattack on Stryker wiped systems globally—what it reveals about hidden third-party risk in clinical trials and what biotech and pharma sponsors should do now.
