Xavier University Health

MDIC Case for Quality Metrics Workshop

FDA Officals Register Here

Better Informed Decisions that Trigger Decisive Action!

Join this engaging workshop on Tuesday, May 2, 2017, to move your organization from one that just collects data, to one that increases in-market successes by using meaningful metrics. Learn how more informed decisions can both trigger needed actions, and drive the Right-First-Time mentality closer to the initial days of development.  Xavier University co-led the medical device metrics initiative with FDA through the Medical Device Innovation Consortium (MDIC).  Learn from the leaders of this work how to implement metrics in your organization in a meaningful way!


Learn directly from those who led the initiative!

Workshop Discussion Leaders:

Sean_Boyd                      Marla-Phillips-Headshot
Sean Boyd                                    Marla Phillips
Deputy Director                          Director
Regulatory Affairs                       Xavier Health
Office of Compliance,

Francisco Vicenty             
Francisco Vicenty                          Monica Wilkins
Case for Quality                            Divisional Vice President
Office of Compliance,                  Abbott
Program Manager


Hands-on working sessions will enable you to return to your organization and implement what you have learned.

The Workshop Experience:

  • You will have opportunity to engage with the Workshop Discussion Leaders and your colleagues on questions you have and successful practices to help with your success.
  • You will work through methodologies you can use with your work teams to identify metrics that are most meaningful to your organization, operations, and products.
  • You will be engaged in discussions, idea generation, and solutions.

Benefits from attending:

  1. Discover how to increase your successes by implementing the FDA/Xavier medical device metrics across the Total Product Lifecycle.
  2. Understand the FDA Case for Quality vision and strategic priorities as they relate to metric implementation, and how they can impact your organization.
  3. Learn how to identify metrics that your organization needs, and how to identify metrics in areas of the Total Product Lifecycle that are vital, but not typically quantified.
  4. Develop a master plan for leading an Effective Management Review Process – moving beyond the meeting itself to total employee ownership.
  5. Understand the power of data aggregation to reveal actionable insights you might not have through traditional metrics methods.
  6. Earn valuable CEUs – 0.4 CEUs offered through this workshop

You should attend if you are:

  • Involved in developing, tracking and using metrics within your organization,
  • Involved in internal audits, external audits, and due diligence audits,
  • A senior leader who needs to get your fingers on the pulse of your organization in a way that will inform decisions and trigger action, or
  • A cross-functional team member who is being measured – own your own metrics and outcomes.

Topics to be covered:

  • FDA Case for Quality Vision and Strategic Priorities for 2017-2018
  • Methodology used to identify the metrics that will be most meaningful for your organization
  • Implementation of the FDA/Xavier medical device metrics
  • The power of metric aggregation
  • Creating an effective management review process


  • Date:  May 2, 2017
  • Time:  11:30 – 4:00 (includes a hot lunch at 11:30)
  • Location:  Xavier University Cintas Center – Training Room Level
    Schiff Family Conference Center
    Cintas Center at Xavier University
    1624 Herald Avenue, Cincinnati, Ohio 45207


$525 (includes lunch)
*Free for FDA
**  4th person free from any organization (contact Stacie Ball to register the 4th person:  balls2@xavier.edu, 513-745-3483)

Join us for Case for Quality Metrics Workshop, May 2, 2017.
 The FDA/Xavier MedCon Conference begins with an evening Welcome Reception on May 2nd.  Join us for the conference May 2-5th after the workshop (www.XavierMedCon.com)


FDA Officals Register Here

You qualify for a 4th FREE registration, please contact us for more details before filling out your registration!