Supplier Management for Medical Device Manufacturers

Supplier selection and management is a fundamental issue faced by medical device manufacturers. Suppliers are critical to the performance and safety of your device as well to your business.

Neither the FDA nor your notified body regulates suppliers (with a few exceptions). Instead, they expect you have an effective process that ensures your suppliers perform. The regulators hold you responsible and verify your controls through inspections and audits. Consequently, you need to understand and implement the regulatory requirements for supplier management. You should pass an audit or inspection without any issues.

This course delivers the tools, templates, and methods to help participants implement an effective, efficient, and compliant supplier management program.

This two-day hands-on workshop provides a clear understanding of the underlying principles of supplier management, using exercises to help illustrate the points and solidify understanding. In addition, the course uses FDA Warning Letters to raise issues and help you learn from others. As part of the practical implementation, the course includes supplier evaluation and selection; measuring, monitoring, and re-evaluation; outsourced processes; supplier auditing techniques; and supplier issues in management review.