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 comply with all FDA requirements and yet make a high-quality device.
“Want to learn how to avoid quality problems? Then download the fourth paper in “The Future of Change & Configuration Management in the Med-Tech Industry“ series sponsored by Siemens PLM and Deloitte.
[restrict]To access this White Paper, click here: Don't Solve Quality Problems, Avoid Them
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