MDICx: Accelerate Sustainable Capability (ASC) Information Session

Wednesday, October 28, 2020, 2 pm ET

Join MDIC in a discussion with the Accelerate Sustainable Capability (ASC) pilot study stakeholders as they describe the intent of the pilot study and the collaboration among all stakeholders to define a pilot study that supports and helps manufacturers improve both performance and compliance. The Pilot was designed in collaboration with  the medical device industry, Information Systems Audit and Control Association (ISACA), Mgmt-Ctrl, and the U.S. Food and Drug Administration (FDA); and leverages lessons learned from the existing Case for Quality Voluntary Improvement Program (CfQ VIP) Pilot and modifies its use for sites that are struggling to meet regulatory compliance. The goal of this pilot is to test a quality system maturity and integration approach to provide manufacturers with systemic insight that may enable FDA 483 and/or advisory actions to be closed faster and more sustainably while also structuring the manufactures systems for continuous improvement. MDIC announced the ASC pilot study July 29, 2020 and there is no cost to manufacturers to enroll or participate. Sites may seek enrollment on the MDIC Website.
The application period will remain open until nine sites have been approved for participation.

  • Kathryn Merrill, Global Quality/Regulatory Program Director, Medtronic Inc.
  • Bleta Vuniqi, Compliance and Quality Staff, Office of Product Evaluation and Quality (OPEQ), Center for Devices & Radiological Health (CDRH)

  • Kim Kaplan, Program Manager, ISACA

  • Larry Mager, Principal, Mgmt-Ctrl, Inc.

  • Becky Fitzgerald, Principal and Co-Founder, Two Harbors

  • Raymond Seda, Senior Director, Compliance/Audit & Quality Operations, Medtronic