US FDA 21 CFR Part 820 Quality System Regulation

USFDA Part 820 covers the processes used in, & the facilities & controls used for the design, manufacture, packaging, labeling, storage, installation & servicing of medical devices.
Manufacturers are inspected by US FDA as per Part 820; however there is no certification process for Part 820 & only compliance with the requirements is assessed.
Operon Strategist does an initial gap analysis of the existing system to determine the extent of development of the quality system.

We guide the clients through documentation & help them to effectively implement it through the various functions of the company.

We also conduct a mock audit to test the effectiveness of the implementation of Part 820 requirements. We also provide post-inspection guidance to clients to help them close any non-conformance observed during the audit.

21 CFR Part 820 – FDA Quality System Regulation

Are you prepared to sell your medical devices in the United States?Provided that this is true, your organization must conform to the US FDA Quality System Regulation (QSR), particularly known as 21 CFR Part 820.

Regardless of the possibility that you as of now have a quality management system must meet this regulation before you can sell your device.

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