Resource Center for Sustained Quality

MDIC’s Case for Quality is setting a cultural shift in motion to focus the medical device ecosystem on sustained product quality that enhances patient safety and outcomes and adds value to stakeholders’ organizations. Collaborating in ongoing Working Groups, representatives from FDA and medical device manufacturers of every size are developing practices, tools and metrics to enhance product design and manufacturing processes and inform regulatory practices.

Find the latest Case for Quality resources, including MDIC working group reports and independent analyses, here.

The Value of Good Quality

The McKinsey & Company report “Capturing the value of good quality in medical devices” examines new analysis and industry examples regarding how improving quality can bring down costs for medical device manufacturers.


Management Review Guidance (For Review) The purpose of this guidance document is to provide life sciences companies a path to an effective quality management review, including suggestions on how to justify the resource and time investment, guidance on what constitutes an effective management review, and examples of management review reports.

Value of Quality – Good Quality is Good Business (For Review) This white paper provides a framework for helping companies identify costs related to poor quality and prioritize investments in good quality. The paper also provides background for the Cost of Poor Quality dashboard that is available here. Being able to understand and leverage Cost of Poor Quality (COPQ) has been identified as a key competency by the Case for Quality Competency working group, providing insight to drive competitive advantage and top line and bottom line performance.

Outcomes Analytics

Medical Device Quality Outcomes Analytics

Providing Value Analysis Committees with reliable medical device quality data to guide purchasing decisions toward better outcomes and cost management is the focus of these observations and recommendations from the MDIC Case for Quality working group on Product Quality Outcomes Analytics. The paper details the team’s work focused on a cross-manufacturer comparative analysis of quality for knee and defibrillator implants.

Released September 20, 2016

Quality Metrics

Medical Device Quality Metrics

Shifting the Right-First-Time mentality as close as possible to initial product development is the focus of the first MDIC Case for Quality guide from the Medical Device Quality Metrics Working Group. This guide details three practical metrics, adaptable to business needs and product complexity, as well as a process for enterprise-wide continual improvement.

Released August 1, 2016

Maturity Model Report

Maturity Model Report

MDIC contracted with Deloitte & Touche, LLC to conduct research concerning the use of maturity models in other industries. Although there are explicit regulations globally for medical devices and diagnostics, there is no recognized quality system maturity model. The objective of this research was to gain an understanding of various maturity models and how they have been implemented and leveraged within other industries. This information will be helpful to devise a plan for the potential development of a maturity model for use by both industry partners and regulators in the Medical Device industry.