The FDA has long supported a quality approach to improve the safety of medical products. The Case for Quality captures the continuing efforts to encourage medical device manufacturers to apply quality principles to their products and operations. The program was started in 2011 after a review showed an investment in quality would have long-term payoffs for manufacturers, hospitals, healthcare providers, payers, and patients. The Case for Quality takes three approaches:
- Promoting critical to quality practices
- Publishing data for independent quality analysis, and
- Engaging stakeholders on quality projects.
There are no pilot projects open for enrollment at this time. Still, there are plenty of resources on the Case for Quality website, including links to quality practice case studies on the websites of stakeholders like Avamed and the American Society for Quality.
Reach out to me if you want to know more or discuss your medical product development challenges.
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Text Copyright © 2020 Katrina Rogers