North America Office
8757 West Cornell Avenue Suite 4
Lakewood, CO 80227 USA
+1 (720) 635-5563

Mexico Office:
Calle Arthur Ashe No. 40
Raquet Club
San Juan Cosala
Jalisco C.P. 45820 Mexico
+1 (720) 635-5563


Documentation systems
Executive and staff cGMP training
GMP Consulting
Internal and supplier audits
Process optimization
Good Manufacturing Practices


21 CFR 820 Quality System Regulation

  • 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 complaint processes?

  • 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!

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Call us today to discuss your specific FDA cGMP, GMP of 21 CFR 820 management system needs!

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