June 27, 2018

Keynote: TOYOTA North America –  Quality Mindset & Culture – Kristen Tabar | Slides •  Video

Panel – Medical Device Industry Perspective – Garth Conrad, Robert Kilenden, Jackie Kunzler, Kristen Tabar | Video

Update on the CDRH Quality Pilot – Francisco Vicenty, George Zack, Kimberly Kaplan | Slides • Video

Envisioning a Maturity Model Dashboard – Scott Ugran | Slides • Video

Quality and Culture – Steve Silverman | Slides • Video

CFQ Strategic Planning and Proposed Workstreams | Slides • Video

Panel – Fitting these new initiatives into the broader Case for Quality – Jeff Shuren, George Zack, Steve Silverman, Joe Sapiente, Beth Staub | Video

November 15, 2017

MDIC Case for Quality – Beth Staub

Keynote: CDRH’s Commitment to the Case for Quality – Jeff Shuren

Implementation of the MDIC Maturity Model work – George Zack and Kimberly Kaplan | Video

Additional information from CMMI

Case study from the CDRH Voluntary Quality pilot – Robert Becker | Video

Update on the CDRH Quality Program pilot – Francisco Vicenty | Video

Additional information about CDRH initiatives

Update: MDIC CFQ Product Quality Outcomes Analytics – Ann Ferriter and Michael Schiller | Video

Panel Discussion: What’s Next for the Case for Quality? | Video

July 20, 2017

Welcome – Bill Murray and Beth Staub | Video

Keynote: Progress on the MDIC National Evaluation System for health Technology (NEST) Coordinating Center – Rachael Fleurence | Video

Real-World Evidence: A CDRH Perspective – Karen Ulisney | Video

Update: CDRH Voluntary Program Proposal – Robin Newman | Video

Preview of the October 10 CDRH Public Meeting on the Case for Quality and the proposed voluntary program – Cisco Vicenty | Video

Panel Discussion: Value Proposition of the CDRH voluntary program | Video

Keynote: Cultural Engineering: Developing a Customer-Centric DNA – John Timmerman | Video

Update MDIC CfQ Analytics Video

Update MDIC CfQ Maturity Model | Video

October 26, 2016

MDIC Maturity Model– George Serafin, Vizma Carver, Becky Fitzgerald, Cisco Vincenty

Medical Device Quality Metrics – Marla Philips and Kristen McNamera

Competency working group update – Pat Baird and Pat Shafer

Product Quality Outcomes Analytics working group update – Ann Ferriter and Mike Schiller

Video demonstration of the Product Quality Outcomes Dashboard

Best practices to improve quality in medical devices – Steve Silverman and Vanya Telpis

MDIC Case for Quality Change Adoption Plan – Sean Boyd, George Serafin and Dwight Abouhalkah

Leadership’s Role in Creating a Quality Culture – Veronia Cruz

CDRH Quality Metrics Project – William MacFarland, Vesa Vuniqi & Roxane Modares
– Draft Language on Proposed Metrics for Pilot

June 28, 2016

Medical Device Quality Metrics – Xavier Health/Xavier University

Metrics at Boston Scientific – Engelke & Dunbar

Value of Quality Metrics – Shkolnik

Metrics – Holmes

FDA Quality Metrics Project – MacFarland

October 8, 2015

2015 Oct 8 – MDIC CfQ Open Forum – Fiorino

Competency Status Update 20151008 v0 – Sapiente

FDA Case for Quality Forum Oct 2015 – Staub n Sapiente

MDIC_CfQ Analytics_AdvaMed_2015_10 – Conrad

MDIC_Open Forum_Quality System Maturity Model_Oct 08 2015 – Serafin

October 8 MDIC Meeting – San Diego.rev2 – Phillips