Reliability Basics –

All QA Professionals Need to Understand this Discipline 

Wednesday, April 24, 2019 7:00 - 9:00 PM

Topic: Back to Basics - The Basics of Product Reliability

§820.30(g) Design Validation: Design validation. Each manufacturer shall establish and maintain procedures for validating the device design. Design validation shall be performed under defined operating conditions on initial production units, lots, or batches, or their equivalents. Design validation shall ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions.

ABSTRACT:

As medical devices continue along a path of increased complexity, greater sophistication is required for a successful qualification program.  This roundtable is intended to discuss best practices for programs aimed at improving the reliability and performance of medical devices.  Topics which will be covered include: