Welcome to the MDIC Resource Library
This library offers a comprehensive collection of reports, studies, and publications for and about the medical device and diagnostics industry. The Resource Library is just one more valuable information-sharing service MDIC offers to the public in order to share the work that we’re doing to advance the future of healthcare for patient benefit.
Science of Patient Input (SPI) Survey on Digital Health Technologies and Patient Input
IMPACT – CfQcc Quarterly Newsletter
Make CAPA Cool White Paper
This white paper is a continuation of a transformational CAPA…
Advanced Manufacturing in Action: A look at Gore’s Digital Transformation
Advanced Manufacturing in Action: A look at Gore’s Digital…
Early Feasibility Studies Electrophysiology Best Practices Workshop Key Insights Report
Advanced Manufacturing Clearing House (AMCH) Overview
Landscape Report & Industry Survey on the Use of Computational Modeling & Simulation in Medical Device Development
Landscape Analysis of 5G in Healthcare
The Landscape Analysis of 5G in Healthcare surveys the role of…
5G Security Enhancements
The 5G Security Enhancements one-page overview outlines several…
How Can Patient Preference Information Be Used in Payer Coverage Decisions and Health Technology Assessment?
The white paper How Can Patient Preference Information be Used…
Using Patient Preference Information in the Design of Clinical Trials Framework
MDIC Medical Device Cybersecurity Maturity: Industry Benchmarking Report 2022
Case for Quality Forum – Leadership Engagement & Voluntary Improvement Program (VIP)
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FDA CASE FOR QUALITY: 2018 COMPREHENSIVE REVIEW
The Medical Device Innovation Consortium (MDIC) has had…
External Evidence Methods Framework
MDIC’s External Evidence Methods (EEM) program aims to…
Playbook for Threat Modeling Medical Devices
Medical devices are increasingly complex systems that exist in…
MDIC Public Forum: RWE in the Context of Payer Decision-Making
IVD RWE Education Series Module 1: Application of the MDIC IVD RWE Framework
The purpose of this series is to provide education on key aspects…
IVD RWE Education Series
The Road to Advanced Manufacturing in the Medical Device Industry
The medical device industry is in a unique position today. The…
Study Design Blueprint for Evaluating Analytical Performance Characteristics of Point of Care In Vitro Diagnostic Devices with Capillary Whole Blood (Fingerstick) Specimens
Maximizing Patient Input in the Design and Development of Medical Device Clinical Trials
Patient Engagement in Clinical Trials – Literature Review
This document provides an updated Literature Review for the…
MDIC Patient Engagement Forum Lessons Learned
The Medical Device Innovation Consortium (MDIC) Virtual Patient…
Patient Engagement in Clinical Trials: Patient, Industry, and Clinical Investigator Perspectives
Case for Quality Video Series
Emerging HealthTech Series: Case for Quality
Learn more about…
Learn more about…
Frequently Asked Questions about the ASC Pilot Study
Leadership Engagement Playbook
A culture of quality in life sciences organizations transcends…
Accelerate Sustainable Capability Pilot Study: Pilot Site Playbook
The objective of this pilot study is to leverage a quality system…
Case for Quality Forum: December 7-8, 2020
MDIC-FDA Workshop: Advancing EUA IVD Products Toward Full Marketing Status
Best Practices for Communicating Benefit, Risk, and Uncertainty for Medical Devices
Appropriate communication of benefits, risks, and uncertainty…
Real-World Clinical Evidence Generation: Advancing Regulatory Science and Patient Access for In Vitro Diagnostics (IVDs)
The MDIC In Vitro Diagnostic (IVD) Real-World Evidence (RWE)…
Screening Consent Form: Informed Consent and HIPAA Authorization
Cardiology Research at Columbia University Irving Medical Research…
2019 EFS Best Practices Workshop
EFS Symposium: Implementation Strategies for Early Feasibility Studies at TVT 2019 Structural Heart Summit by the Cardiovascular Research Foundation
Following the MDIC’s EFS Site Best Practices workshop in March…
CAPA Process Improvement Auditor Training
This online training course was developed to provide users with…
Case for Quality Forum: March 12, 2020
Welcome and Introductions
Download Slides
MDIC…
Download Slides
MDIC…
EFS Budgeting Best Practices Workshop
February 26, 2020
In 2017 and 2019, MDIC collected…
In 2017 and 2019, MDIC collected…
NESTcc Methods Framework
The NESTcc Methods Framework is applicable to many different…
NESTcc Data Quality Framework
The NESTcc Data Quality Framework focuses primarily on the use…
Incorporating Patient Perspectives in Clinical Trial Design and Research
Parkinson’s patients Margaret Sheehan and Anne Cohn Donnelly,…
EFS Express Archive
Case for Quality: CAPA Process Improvement
Case for Quality Forum: November 6, 2019
MDIC held its final Case for Quality Forum of 2019 on November…
EFS Symposium: Implementation Strategies for Early Feasibility Studies Presentations
On June 12, 2019, MDIC partnered with the Cardiovascular Research…
Clinical Diagnostics Somatic Reference Samples Request for Proposals
View a Q&A webinar about this Request for Proposals here…
Framework for Developing Clinical Evidence for Regulatory and Coverage Assessments in In Vitro Diagnostics (IVDs)
This Framework is intended to help test sponsors make decisions…
Surrogate Sample Harmonized Education Modules
Surrogate samples, when properly used, can not only decrease…
Case for Quality Forum: June 20, 2019
Keynote Panel: Intersection of Quality and Cybersecurity
Intersection…
Intersection…
Patient Engagement in Clinical Trials Survey Report
MDIC surveyed 53 device and diagnostic industry stakeholders…
Literature Review: Patient Engagement in Clinical Trials
This document provides an updated Literature Review for the Medical…
Case Study: Using the MDIC Patient-Centered Benefit-Risk Framework to Support an Expanded Indication
Home hemodialysis device manufacturer, NxStage, used the MDIC…
Clinical Diagnostics Somatic Reference Samples Request for Information (RFI)
This RFI is a request for technical information about available…
SRS Landscape Analysis Report
The Landscape Analysis report was created from the work conducted…
Case for Quality Forum: February 25, 2019
Below are downloadable files from the Case for Quality Forum.
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MDIC PCOR Project: From P-Values to Patient Values in Parkinson’s Disease Workshop Summary
On May 18, 2018, MDIC convened a workshop to discuss the outcomes…
Additional Resources & FAQ’s about Conducting Patient Preference Studies
Patient Preference Consultants and Experts list
Case for Quality Forum: November 27, 2018
Welcome and goals for the day – Beth Staub | Slides
Keynote:…
Keynote:…
Patient Centered Benefit-Risk (PCBR) Framework
Press Release: Patient Preference Collaboration
Patient Centered Outcomes Research Project Overview
TVT 2017 EFS Presentation
EFS/FIH Perspectives Report
MDIC EFS Blueprint
EFS Background Information: IRBs and Site Study Staff
When hospital administration, research staff and IRB members…
Patient Introduction to Consent for Early Feasibility Studies
EFS Patient Informed Consent Form template
A template of a patient Informed Consent Form (ICF) for adult…
EFS Master Clinical Trial Agreement (MCTA)
Early Feasibility Study (EFS) Contracting Resource: Negotiation Range Process and Language Libraries
2017 MDIC EFS Metrics Report: Administrative and Clinical Practices
EFS Participant Landscape
Maturity Model Report
Medical Device Quality Metrics White Paper
Medical Device Quality Outcomes Analytics Report
Capturing The Value Of Good Quality In Medical Devices
Video: Dr. Jeff Shuren, Director of CDRH, FDA Discusses Case for Quality
Resource Center for Sustained Quality
Somatic Reference Sample Project Proposal
Surrogate Sample Use Survey Results
Surrogate Sample Framework
Medical Device Cybersecurity Report
Cybersecurity in the Medical Device Sector: Coordinated Vulnerability Reporting RFP
Q&A with Marc Horner
The technical lead for health care at ANSYS reflects on current…
Q&A with Kyle Myers
MDIC Computer Modeling and Simulation (CM&S) project FDA…
Case for Quality Open Forum: September 27, 2018
Welcome and goals for the day – Joe Sapiente | Slides
Fixing…
Fixing…
Case for Quality Open Forum: June 27, 2018
Keynote: TOYOTA North America – Quality Mindset & Culture…
Case for Quality Open Forum November 15, 2017
MDIC Case for Quality – Beth Staub
Keynote: CDRH’s Commitment…
Keynote: CDRH’s Commitment…
Case for Quality Open Forum July 20, 2017
Welcome – Bill Murray and Beth Staub | Video
Keynote:…
Keynote:…
Case for Quality Open Forum Focused on CfQ Working Groups and Adoption Plan Recommendations October 26, 2016
MDIC Maturity Model– George Serafin, Vizma Carver, Becky Fitzgerald,…
Case for Quality Open Forum Focused on Product Quality Metrics June 28, 2016
Medical Device Quality Metrics – Xavier Health/Xavier University
Metrics…
Metrics…
Case for Quality Open Forum May 10, 2016
May 10, 2016 – Case for Quality Open Forum Replay
May 10,…
May 10,…
Case for Quality Open Forum October 8, 2015
2015 Oct 8 – MDIC CfQ Open Forum – Fiorino
Competency…
Competency…
Case for Quality Open Forum June 24, 2015 Online
Webinar Presentation
