Navigating FDA Changes: What Life Sciences Professionals Need to Know The FDA plays a critical role in regulating medical devices, pharmaceuticals, and biologics, ensuring the safety and efficacy of healthcare products. However, with recent political [...]

Enhancing Quality Processes: ComplyFDA’s Insightful Approach to Baseline Assessments Recently, Michael Kuehne at ComplyFDA conducted a deep dive into developing a baseline assessment using a risk-based approach looking at all quality processes. This approach delivers [...]

“It’s a full thickness tear of your right rotator cuff.” Not words I ever wanted to hear, let alone leading up to a holiday. But this diagnosis gave me the opportunity to consider the safety [...]