Description: Risk Management for In-vitro diagnostic (IVD) products can be a complex process with hardware, software, reagents, and potentially buffers, diluents,calibrators and wash solutions involved in a single diagnostic result. There has been lively debate and differing opinions on how to analyze anddocument risks and medical benefits associated with IVDs. Selection of Risk Management methods to support marketing claims and satisfy pre-marketand post-market regulatory requirements, while also balancing cost, complexity and ability to sustain operations is of utmost importance. This sessionwill evaluate and discuss the challenges and opportunities associated with different approaches to IVD Risk Management, specifically assaymanagement vs. product and process management. The session will cover strategic approaches to align risk management with claims and labelling and post-market surveillance for the United States, the European Union and rest of world (ROW).
Learning Objectives:
Describe advantages and disadvantages to various approaches in IVD risk management methods.
Explain the potential marketing and compliance challenges when inappropriate risk management methods are selected
Describe advantages and disadvantages of various risk management methods in the post-market surveillance process.
