Risks to a medical device’s performance can occur at any stage of the product lifecycle, as highlighted at the 2015 Risk Management Summit conducted by AAMI. Sometimes, changes in a product may be so ...

Successful risk management is essential to the design and development of safe and effective medical devices. Unfortunately, it is too often viewed by manufacturers as an isolated activity that must be ...

A PQRI expert working group provides case study examples of risk-management applications. The harmonized Q9 Quality Risk Management guideline from the International Conference on Harmonization (ICH) ...

Navigating the intricacies of compliance and risk management can seem overwhelming for businesses, especially those operating in heavily regulated industries. The rules are complex and the stakes are ...

Today’s fast-moving world demands that risk management be an imperative more than ever before. From shifting global economic futures and environmental challenges to increased development in new ...