Two Day Supplier Management for Medical Device Manufacturers Workshop: San Francisco, CA, United States – March 29th-30th, 2018


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.

The workshop uses the Global Harmonization Task Force (GHTF) framework, but expands it to cover other important issues and techniques. The course includes information from the ISO 13485:2016 Handbook, FDA's QSIT, and the MDSAP Audit Model.

Multiple exercises, guidance documents, tools, and templates help you implement an effective program.

Learning Objective:

  • Understand FDA QSR and ISO 13485:2016 requirements for supplier management
  • Learn FDA's inspection techniques from QSIT
  • Understand supplier management tasks from the MDSAP Audit Model
  • Understand the FDA's multi-tier supplier classification system
  • Understand when suppliers have to register and list with the FDA
  • Use an analysis matrix and radar chart to compare suppliers
  • Explain the link between design control and purchasing data
  • Develop an overall supplier management plan
  • Understand how to develop and implement supplier controls
  • Create receiving inspection criteria and apply them as part of supplier controls
  • Create supplier measurement, monitoring, and re-evaluation processes
  • Create a system for supplier business risk
  • Create a system for supplier regulatory risk
  • Create a risk based system for supplier audits
  • Develop a supplier audit using the backward tracing process approach

Who Should Attend

  • Quality Managers
  • Supply Chain Managers
  • Quality Engineers
  • Supplier Quality Engineers
  • Purchasing Professionals
  • Regulatory Specialists
  • Production and Process Engineers


Day 01 (8:30 AM – 4:30 PM)

08.30 AM – 09.00 AM: Registration

09.00 AM: Session Start

Part A – Regulatory Requirements

  • Status of the regulations
  • Supplier management in FDA QSR & ISO 13485:2016
    • QSIT and the MDSAP Audit Model
  • EU MDD and MDR
  • Unannounced visits
  • Supplier Evaluation and Selection
    • When suppliers have to register and list with FDA
    • Outsourced processes
  • Purchasing Data
  • Acceptance activities

Part B – Planning for Supplier Management

  • Supplier management as a business process
  • The business risk model
  • The regulatory risk model
  • The medical device risk model

Part C – Planning for Supplier Selection

  • Identifying what to procure
  • Design control and purchasing data
  • Identify risks (business, regulatory, and device)
  • Identify controls (business, regulatory, and device)
  • Special considerations
    • UDI
    • Control numbers
    • RoHS
    • Conflict Minerals

Part D – Potential Suppliers

  • Identify potential suppliers
  • Evaluative business capability
  • Evaluate operational capability
  • Using an analysis matrix and a radar chart

Day 02 (8:30 AM – 4:30 PM)

Part E – Supplier Selection

  • Sole source v. single source
  • The directed procurement problem
  • Selecting the supplier
  • The Approved Supplier List

Part F – Implementing Supplier Controls

  • Building the final control plan
  • Receiving acceptance as a supplier control
  • Developing hidden controls
  • The supplier quality agreement
    • Standalone v. part of the contract

Part G – Monitoring, Measuring, and Evaluation

  • Standard supplier metrics
  • Implementing predictive analysis
  • Developing a supplier audit program
  • Using the supplier's QMS certificate
  • The backward tracing process audit
  • Supplier management as part of Management Review
    • Outsourced processes

Part H – Feedback and Communication

  • Supplier scorecards
  • Corrective action requests

Part I – Evaluating your program

  • Supplier management maturity models
  • FDA's QSIT
  • MDSAP Audit Model
  • GHTF guidance on auditing supplier control
  • Case Study and exercise on maturity models

For more information about this conference visit

Media Contact:

Research and Markets
Laura Wood, Senior Manager
[email protected]

For E.S.T Office Hours Call +1-917-300-0470
For U.S./CAN Toll Free Call +1-800-526-8630
For GMT Office Hours Call +353-1-416-8900

U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716

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SOURCE Research and Markets

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