FDA’s Pilot Program Helps Achieve Continuous Improvement of Product Quality for Improved Patient Safety as the Ultimate Outcome

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.

A growing number of companies have joined the FDA Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot. Officially launched in December 2017, the initiative now includes 24 facilities at 16 leading organizations such as Siemens, Medtronic, Baxter Healthcare, and Boston Scientific.

This pilot program leverages a maturity model by which medical device organizations may measure their capability to produce high quality devices and increase patient safety. FDA will adjust their engagement activities and submission requirements as a recognition of this independent assessment of quality maturity.

In this pilot, FDA is adjusting engagement activities and submission requirements in recognition of independent quality appraisals. The goal is to move the medical device industry from a single-minded focus on compliance to a mindset that blends continuous improvement and product quality with improved patient safety as the ultimate outcome.

Medical device standards 21 CFR Part 820, ISO 13485, and others are not impacted by this FDA Case for Quality initiative. Instead, the program is attempting to change the process for meeting these requirements. The original motivation for creating this program came about years ago when FDA noticed little difference in the number of medical device product issues at companies with excellent compliance records versus those with average or poor compliance. Surprised by this result, regulators, industry stakeholders and other groups responded by looking for new ways to produce both good compliance and higher levels of product safety.

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.

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