Free Book - Hazard Analysis Primer
Build a deeper understanding of hazard analysis by learning from techniques developed in the aerospace industry.
Note: available to customers in the US only
Case Study - FDA Warning Letter
Learn how failing to update your risk matrix based on post-market surveillance can lead to a FDA warning letter and best practices to avoid this situation.
Audit Preparation Tips
Learn why it is critical to clearly understand the auditor's perspective and prepare well to achieve a successful outcome in an audit of your risk management system.
Case Study - Class I Recall
Learn how failing to recognize new hazards or hazardous situations arising from risk control measures can lead to a Class I recall, and best practices to avoid this situation.
Benefit-Risk Analysis Case Study
Benefit-risk analysis proves to be challenging in practice because there is no cookie-cutter formula. Here are some practical tips using a case study from the FDA.