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.
June 10, 2019
March 4, 2019
Below are downloadable files from the Case for Quality Forum.
- Welcome from ASQ | American Society for Quality
- MDIC Overview Presentation | Medical Device Innovation Consortium
- MDIC CfQ Presentation | MDIC Working Group
- Advancing Quality and Regulatory Science | CDRH: OIR / FDA
- Medical Device Discovery Appraisal Program | CMMI, CDRH/ FDA, Two Harbors Consulting
- Reflections on Illumina’s MDDAP/VIP Appraisal | Illumnia
- 501(k) Program Improvement Project | NSigma Solutions
- #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
Current as of October 25, 2019