In this article, we examine common root causes behind regulatory setbacks, development delays, and failures to adequately address patient needs. We discuss the first principles of safety and how applying these principles helps organizations stay focused and navigate complexity across development and lifecycle management with confidence.

The article discusses what safety means, how the device manufacturers develop effective device safety argument, and how the regulators perform effective safety review.

The article highlights key principals (and pitfalls) for effective risk management and emphasizes the importance of effective risk management in advancing regulatory science.

FDA Public Workshop “FY 2019 Generic Drug Regulatory Science Initiatives Wednesday, May 1, 2019”

Cybersecurity risk management for Medical Devices is now expected by FDA. How to do it as a device manufacturer who has been practicing safety risk management? Read this article and find out ways to fully leverage your safety risk management practices for cybersecurity risk management.

Confused with risk management terms (e.g. harms, hazards, hazardous situations, causes)? Read this article and find out best practices how to distinguish them.

Is FMEA alone adequate for risk analysis? How to document a comprehensive risk analysis? Read this article to get some insights from the experts.

Find out FDA's thinking about risk management and safety cases.

Ever wondering how to improve your risk management methods and practices? Read this article to get some insights on how safety assurance cases can help.