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US FDA 21 CFR 820
Quality System Requirements Management
Systems
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Manufacturing medical
devices?
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Plan to sell your products in the US?
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Need to comply with FDA 21 CFR 820 QSR?
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Want to improve field action and customer
complaint processes?
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Wish you could do things right the first
time?
We can help! Quality Works assisted dozens of companies worldwide to establish and implement effective
Quality Management Systems meeting requirements of the US Food and
Drug Administration (FDA) QSR.
A Quality Management System compliant with these regulations is mandatory for a
medical device manufacturers producing or selling their products in
the US. While FDA QSR requirements are well aligned with ISO
13485 standard, there are additional requirements for process control, design control, retention of records, traceability, compliance with regulatory requirements and
others. You may download
FDA QSR from the
FDA Website. To compare ISO 13485 with FDA QSR, check the correspondence matrix on our
Download page. Check our Products page
to see how our documentation sets can help you in developing your
Quality Management System or call us for a free, no obligation
consultation. We can help!
Call us today to discuss
your specific ISO management system needs!
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