Sign Up

Your Profile will be reviewed by Admin
May 2015
May 2015


DoubleTree by Hilton Hotel San Diego Downtown 1646 Front Street San Diego , California 92101
Tel: (888) 717-2436
Google Map

Managing Suppliers in the Medical Device Industry - BY Dan O'Leary

25 0


Event Overview:


Two Day In-Person Seminar 

Program Overview:

Device manufacturers face issues and confusion when setting up and maintaining a supplier management program. Some of this confusion results from the regulations. While they contain requirements, the details are dependant on the device manufacturer’s ability to create an effective and efficient system.
This course helps the device manufacturer through a unique format of explanation, discussion, and practical application. The course is built of modules based on the Global Harmonization Task Force (GHTF) guidance document on the control of products and services obtained from suppliers. It describes the necessary controls in a model that includes six phases:

  • Planning
  • Selection potential suppliers
  • Supplier evaluation and acceptance
  • Establishing controls
  • Delivery, measurement, and monitoring
  • Feedback and communication, including Corrective Action and Preventive Action processes


The course follows these phases and explains the regulatory requirements in the Quality System Regulation (QSR), ISO 13485:2003, the Medical Device Directive (MDD), EN ISO 13485:2012, and other requirements. Participants discuss each phase, using discussion points from the course material and apply multiple points of view: QMS implementers, internal auditors, external auditors, and FDA Investigators. Practical applications include situations, often based on FDA Warning Letters, in which participants work on methods to prevent the situation and to respond should it happen.
The course includes major topics that currently create problems. Among these are:

  • Determining when a supplier is a contract manufacturer
  • Deciding on a required QMS for a company that makes only components
  • When to rely on the supplier’s third party QMS certificate
  • When to conduct second party audits and establishing their scope
  • Preparing suppliers for unannounced visits based on the MDD and EU expectations
  • Creating requirements for UDI when the supplier is involved in the device label
  • The role of medical device risk management, ISO 14971:2007, for component suppliers


Course Objectives:

Upon course completion, participants will:

  • Understand FDA QSR and ISO 13485:2003 requirements for supplier management
  • 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 the how to develop and implement supplier controls
  • Create receiving inspection criteria and apply them as part of supplier controls
  • Create supplier measurement and monitoring systems
  • 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 trace process approach


Meet Your Instructor

Dan O’Leary

Dan O’Leary has more than 30 year’s experience in quality, operations, and program management in regulated industries including aviation, defence, medical devices, and clinical labs. He has a Masters Degree in Mathematics, focusing on logic and number theory. His professional experience relates to quality, regulatory, reliability, and operations management.

Dan is a regular speaker at international conferences including ASQ, ISM, and RAMS. Dan teaches courses in reliability methods, medical device regulations and practices, statistical methods, management systems (ISO 9001, FDA QSR, & ISO 13485), and project management. Dan is an ASQ Certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; he holds an APICS certification in Resource Management.


MORE events +

Display Makers +