The Paradigm Shift in Quality Regulatory Standards- How it Helps Medical Device Companies Evolve

Compliance managers at prominent medical device companies are collaborating with the U.S. Food and Drug Administration to reinvent the methods for meeting quality regulatory standards. Supporting this vision, the next generation of cloud-based quality management systems brings modern, collaborative, web- and mobile-friendly productivity to help compliance professionals prepare for this new world.It won’t be easy to change years or decades of compliance conformity into a culture that integrates product quality and continuous improvement. However, those firms that employ new cloud-based electronic quality management systems (EQMS) are well positioned to adapt to this changing regulatory approach with the latest in flexible, secure, and scalable compliance management tools that are fully integrated with other enterprise applications.

Moving away from a traditional understanding of compliance to prepare for FDA’s approach requires new thinking.

Old Paradigm New Paradigm
Quality Requirements increase the cost of our products Quality is free
The Quality Organization is the police The Quality Organization helps ensure predictable outcomes
Compliance is a goal in and of itself Compliance happens naturally when we operate in State of Control
State of Control only applies to items in the Quality System State of Control is a concept that applies to everything we do

Too often, the traditional approach to compliance included reactive adoption of quality solutions, resulting in a collection of disparate systems with little visibility across the enterprise. In the new paradigm, the emphasis on collaboration with internal and external stakeholders, plus integration across business functions in support of continuous improvement, supports implementation of modern 100% cloud- based EQMS to help medical device companies evolve.

Following tradition has caused the medical device industry to fall decades behind in its approach to quality, resulting in capabilities which are significantly lower than other industries. As proof, consider the six-sigma defects-per-million evaluation comparing airline baggage handling and medical device manufacturing. Airlines achieve a score of more than 4 sigma while medical device companies lag behind, scoring less than 4 sigma.

In the new Case for Quality initiative, all 16 participating medical device companies report they would recommend participation to other organizations, according to program effectiveness metrics published by the Capability Maturity Model Integration (CMMI) Institute, which plays a key role in the new regulatory overhaul.

FDA and other supporting organizations such as the Medical Device Innovation Consortium are also encouraged by the results to date. Officials expect a total of 30 companies to join the program by the end of 2018 and say they will expand it more fully in years to come.
Current program metrics also show that 89.4% of the participants found the medical device facility appraisals helpful in identifying areas or processes that could improve how work is performed to increase product quality. This metric reflects progress in meeting the program’s continuous improvement goals.

Medical device companies both inside and outside the program that are using EQMS get an integrated picture of quality across the organization, which enhances their ability to focus on continuous improvement. And those organizations using EQMS that are 100% cloud based can realize continuous improvement benefits through improved collaboration, better risk management, easy data access, analytics and artificial intelligence and more effective overall compliance management.

About ComplianceQuest

The vision at ComplianceQuest is to transform quality and compliance into a strategic advantage for our customers through experience, expertise and passion. ComplianceQuest is an innovative, 100% cloud based Enterprise Quality Management System solution company. We provide an enterprise grade solution that streamlines quality, compliance, content and collaboration management initiatives and strategies across diverse, globally based supply chain networks.

For more information, or to request a demo with a ComplianceQuest expert, contact ComplianceQuest today.

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