US FDA 21 CFR 820 Quality System Requirements Management Systems

• Manufacturing medical devices?

• Plan to sell your products in the US?

• Need to comply with FDA 21 CFR 820 QSR?

• 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) 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!