Manufacturing medical devices?
Plan to sell your products in the US?
Need to comply with FDA 21 CFR 820 cGMP?
Want to improve field action and customer
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) current Good Manufacturing Practices (cGMP)
and 21 CFR 820 QSR requirements. A Quality Management System compliant with these regulations is mandatory for
medical device manufacturers producing or selling their products in
the US. While FDA QSR and GMP 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 view
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 cGMP
compliant Quality Management System or call us for a free, no obligation
consultation: we will be glad to assist you!
Discover techniques to build Lean Management Systems.
Download a complimentary copy of our
The Perfect Manual - A Guide
to Lean Management Systems book
Call us today to discuss your specific
FDA cGMP, GMP of 21 CFR 820 management system needs!