The FDA’s CDRH has launched a pilot program to accelerate public communication of high-risk medical device recalls. Learn what this means for manufacturers and how to prepare your recall and risk management systems. […]

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 shifts, leadership changes, and funding concerns, the regulatory landscape is [...]

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 actionable improvement recommendations and incorporates validated best practices to [...]

“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 [...]