Description: Regulatory requirements and expectations of competent authorities and notified bodies seem to always be changing. How can an in-vitro diagnostic manufacturer plan for design and development to ensure the clinical evidence generated will be suitable for market access across multiple global markets? This session will discuss strategic approaches to plan and document performance evaluation for IVD devices in a manner that can address multiple markets (Europe, the United States, and 1-2 Asian markets).
The session will describe how this can streamline the registration processes and shorten the time to launch in these markets by enabling simultaneous registration activities. To help understanding, the session will use an example IVD device and work through these scenarios using the example device as a case study. Participants will be able to take back and explain to their development teams how they can work together to shorten the time to get their IVD device to market across multiple geographies.
Learning Objectives:
Understand the current regulatory environment for IVD devices in Europe, the US, and 1-2 Asian markets.
Identify strategies for planning and documenting IVD performance evaluation to address regulatory requirements and expectations for multiple geographies.
Describe for their company’s development team how to plan and document development activities to shorten the time to market across multiple geographies.
