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Medical Device 2021 - US FDA Medical Device QSR, 21 CFR 820 and Quality Management System



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Learn the basic overview of the original medical device Quality Management System -- The US FDA’s CGMP, Quality System Regulation (QSR) under 21 CFR 820. Implementation, training requirements and content, and annual internal audit / inspection expectations.
In the U. S., the Quality System (QS) Regulation (21 CFR Part 820) governs the manufacturing of medical devices, the device CGMPs. What is the importance, and purpose, and the framework of basic requirements for design and manufacture of medical devices
What are US FDA expectations for a compliant device QSR?
How can a company develop and maintain a dual QMS.
Basic Systems / SOPs.
John E. Lincoln is Principal of J. E. Lincoln and Associates LLC, a consulting company, with over 32 years experience in U.S. FDA-regulated industries,

Last modified: 2021-07-09 23:50:39