Case for Quality Forum: February 25, 2019

March 4, 2019

Below are downloadable files from the Case for Quality Forum.

  1. Welcome from ASQ | American Society for Quality 
  2. MDIC Overview Presentation | Medical Device Innovation Consortium 
  3. MDIC CfQ Presentation | MDIC Working Group 
  4. Advancing Quality and Regulatory Science |  CDRH: OIR / FDA 
  5. Medical Device Discovery Appraisal Program | CMMI, CDRH/ FDA, Two Harbors Consulting 
  6. Reflections on Illumina’s MDDAP/VIP Appraisal | Illumnia 
  7. 501(k) Program Improvement Project | NSigma Solutions 
  8. #MAKECAPACOOL | MDIC Working Group 

 

 

 

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Case for Quality Forum: November 27, 2018

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

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Maturity Model Report

November 19, 2018

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Medical Device Quality Metrics White Paper

November 19, 2018

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Medical Device Quality Outcomes Analytics Report

November 19, 2018

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Medical Device Cybersecurity Report 

November 19, 2018

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