Risk Management And The Combination Product Testing Strategy

Understanding combination product risks at the interfaces is critical. Components are often sourced at opposite ends of the globe and are proven to be robust due to investments in research, development and testing. It is essential to have an equal and complete understanding of all components where they come together at the interfaces where the risks are hidden. Understanding the essential performance of the combination product at all stages is a win-win for the patient and all stakeholders within the supply chain.