Case for Quality Forums

Case for Quality Forum: November 27, 2018

Welcome and goals for the day – Beth Staub | Slides

Keynote: Building Digital Analytics Foundation for Autonomous Factories at Western Digital – Attila Lengyel | Slides

Results of the CDRH Voluntary Medical Device Manufacturing and Product Quality Pilot – George Zack, Kim Kaplan, Francisco Vicenty | Slides 

What we learned from the pilot – Kim Kaplan | Slides

MDIC Governance Survey Results – George Serafin |Slides

What’s Next? – Francisco Vicenty |  Slides


Case for Quality Open Forum: September 27, 2018

Welcome and goals for the day – Joe Sapiente | Slides

Fixing CAPA – David Gustafson | Slides

Quality as a Career Option – Adrienne Brott | Slides

Engaging the C-Suite – Joe Sapiente | Slides

Safe Space for Collaboration – Conor Dolan | Slides

Program Quality Outcomes Analytics – Dan Matlis | Slides 

CDRH update – Francisco Vicenty | Slides

Case for Quality Open Forum: 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 | SlidesVideo

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

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Case for Quality Open Forum

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

Case for Quality Open Forum

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

Case for Quality Open Forum Focused on CfQ Working Groups and Adoption Plan Recommendations

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

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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


Case for Quality Open Forum Focused on Product Quality Metrics

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


Case for Quality Open Forum

May 10, 2016

May 10, 2016 – Case for Quality Open Forum Replay

May 10, 2016 – Case for Quality Open Forum Presentations


Case for Quality Open Forum

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

Case for Quality Open Forum

June 24, 2015


Webinar Presentation