Quarterly update on the CDRH Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot program
February 27, 2018
From stories to evidence: Quantitative patient-preference information to inform product-development and regulatory reviews
February 15, 2018
Framework for Surrogate Sample Use in Clinical Diagnostic Test Development and Product Submission – from the MDIC Clinical Diagnostics Surrogate Samples Working Group
December 12, 2017
A Case Study in How Patient Preference Information Contributes to Regulatory Decisions for Medical Devices
December 4, 2017
Patient values and P-Values: Exploring a new method for developing patient-centered clinical trials
November 17, 2017
Virtual Patient R Code Access and Use
May 18, 2017
Leveraging Existing Information for Future Studies: The Case for Bayesian Methods
April 17, 2017
MDICx – Quality Metrics: Best Practices, Cases Examples and How Metrics Factor into the Case for Quality
April 6, 2017
MDICx: Draft Framework for Surrogate Sample Use in Clinical Diagnostic Test Development and Product Submission – from the MDIC Clinical Diagnostics Surrogate Samples Working Group
April 5, 2017
Survey of Surrogate Sample Use in Clinical Diagnostic Test Development and Product Submission – Report from the MDIC Clinical Diagnostics Surrogate Samples Working Group
March 23, 2017
Making the Business Case for Quality – Reports from the MDIC Case for Quality Competencies Working group
February 14, 2017
Clinical Trial Quality by Design: Factors Critical to Quality
August 10, 2016
The Case for Quality Open Forum
May 10, 2016
Practical considerations for measuring and integrating patient preference information into your regulatory submission
March 15, 2016
The Emerging Case for Medical Device Interoperability Toward a Future of Patient Centered Care
February 23, 2016
