Don’t Solve Quality Problems, Avoid Them

Can you distribute poor quality products while complying with all applicable regulatory requirements?

Sure! After all, you can conduct a recall of poor quality products in compliance with all applicable regulations.

FDA’s Top Medical Device official agrees. Jeff Shuren, M.D., J.D., Director of FDA’s Center for Devices and Radiological Health (CDRH), put it this way: “…one device manufacturer can meet FDA requirements and still make a poor quality device; whereas, a second manufacturer may not . . .

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