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7 QMS Tools to Exhibit 21 CFR Part 820 Compliance for Medical Devices

 

How a Quality Management System Can Ensure Compliance With FDA 21 CFR Part 820

21 CFR Part 820 contains a huge number of “shall” requirements for medical device manufacturers. While it may seem impossible to meet so many requirements, a well-constructed Quality Management System (QMS) provides an excellent starting point and framework for compliance.

So how can manufacturers use the QMS to demonstrate compliance with these regulations, and which tools are most important to getting the job done?

Today’s post looks at just that, focusing on 7 specific capabilities to leverage in the QMS to assist with 21 CFR Part 820 compliance.

Rachel Beavins Tracy
By Rachel Beavins Tracy
on Mon, May 07, 2018
   
7 QMS Tools to Exhibit 21 CFR Part 820 Compliance for Medical Devices

 

How a Quality Management System Can Ensure Compliance With FDA 21 CFR Part 820

21 CFR Part 820 contains a huge number of...

Rachel Beavins Tracy
By Rachel Beavins Tracy
on Mon, May 07, 2018
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