1000855 Speaker Data Sheet, Background

3000023 Supplier Quality Management Utilizing Principles of Lean Documents and Lean Configuration

Background

Many companies have outsourced both their design and manufacturing to specialized suppliers. As new medical device technologies push the boundaries of miniaturization, 3D printing and solid modeling, imaging, drug-device combinations, and new applications, the demand for specialized suppliers has left gaps in the common understanding of medical device requirements. Also, changes to ISO 13485:2016 have required a risk-based approach to all QMS processes – including those associated with supplier management and processes associated with them.

Supplier Quality Management presents the challenges of working through external parties to achieve internal organization objectives.