From stories to evidence: Quantitative patient-preference information to inform product-development and regulatory reviews – Instrument Development

March 15, 2018

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