June 10, 2019

We’ve published our first-ever annual report to share the impact of our work during the 2018 year. This report not only helps quantify and demonstrate the impact we’ve had but also helps us identify opportunities for growth and improvement. Some of the key highlights from the Annual Report include launching the Health Economics and Patient Access initiative, announcing NESTcc’s Real-World Evidence Test-Cases, and publishing a number of tools and resources for stakeholders. We developed and published a report on cybersecurity for medical devices. These accomplishments would not have been possible without the dedicated members of our public-private partnership who help us promote patient access to innovative medical technologies.

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 

 

 

 

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

November 19, 2018

November 19, 2018

November 19, 2018