21 Code of Federal Regulations (CFR) 820

Code of Federal Regulations Title 21 part 820 (QSR 21 CFR part 820) is US FDA Current good manufacturing practice (CGMP) requirements for medical devices. In short, FDA 21 CFR Part 820, also known as the Quality System Regulation QSR which outlines Current Good Manufacturing Practice CGMP regulations that govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labelling, storage, installation, and servicing of all finished medical devices intended for human use and sale in the United States Of America. These requirements are meant to ensure that medical devices are safe and effective. Medical Device manufacturers undergo FDA inspections to ensure FDA QSR 21 CFR 820 compliance.
There is no Certification process for 21 Code of Federal Regulations (CFR) 820, FDA does not require certification, only compliance with the standards is recommended. They will, however, inspect your facility at some point where your organization is registered and products are listed and available in the US Market so that in effect is a "certification" if you pass.

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We provide following service as per US FDA QSR 21 CFR 820 for clients across the globe.

  • Implementation support
  • External GAP analysis and Audit
  • FDA pre-inspection audit
  • FDA Post inspection support for closing non-conformities (FDA 483)

Kindly Contact us for any assistance for the implementation of QSR 21 CFR 820

Reference Documents and Tutorials
21 CFR 820 Presentation – Click Here
21 CFR 820 Guidelines -  Click Here

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