Case for Quality Working Groups


MDIC is currently looking for volunteers to participate in four new working groups aimed to continue the advancement of the Case for Quality. Since 2015, MDIC has been supporting FDA’s launch of the Case for Quality which was developed to elevate the focus of all medical device stakeholders from baseline regulatory compliance to sustained, predictive practices that advance medical device quality and safety to achieve better patient outcomes.

In support of this program, MDIC has published best practices, continued to advance product quality outcome analytics and have helped launch the CDRH Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program. Recognizing there is still more that can be done to advance quality in medical device manufacturing, MDIC’s Case for Quality steering committee has created the following four new working groups:

  • Redesign the CAPA Process as a Continuous Improvement Framework – Leverage cross-industry best practices and collaboration to fundamentally recast CAPA as a continuous improvement framework
  • Create a Cross-Industry “Safe Space”, and Pilot a Predictive Quality Analytics Model – Create a non-competitive, collaborative, and sanction-free environment enabling open discussions on a variety of critical improvement initiatives. Pilot the safe space with an  effort in developing a Quality-centric predictive analytics model in the MedTech industry
  • By 2020, 85% of Medical Device CEOs Engaged in Quality Initiatives – Influence CEOs of medical device companies to participate in quality initiatives in a meaningful way that will effect change in their organizations and the industry. Promote Quality as a “strategic priority” being integral to all parts of an organization through strong leadership, strategic alignment, and tone at the top.
  • Make Quality an Attractive First Step in your Career – Establish a Quality discipline at the College/University level and educate students to the benefits of making Quality a foundational start to a successful career within the MedTech industry

If you are interested in volunteering or would like more information, please contact MDIC Program Director Stephanie Christopher at schristopher@mdic.org.