Supplier Management for Medical Device Manufacturers

How to Meet FDA and ISO 13485 Notified Body Requirements Using Lean Principles

Supplier management – initial selection and ongoing assessment – is a critical issuesfor medical device manufacturers. Suppliers provide components and/or services to the legal manufacturer, which means they are critical to performance and delivery. Neither the FDA nor your notified body regulates your suppliers (with a few exceptions). They expect you to have an effective process to ensure your suppliers perform in the regulatory environment.

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

  • Supplier Qualification
  • Supplier Qualification (cont)
  • Supplier Assessment
  • Supplier Assessment (cont)
  • Supplier Nonconformance
  • Supplier Nonconformance (cont)