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K155
Introduction to FDA Medical Device Quality and Compliance

Susan Marshall, P.E., MBA

This course provides an introduction to FDA Medical Device quality and compliance as defined in 21 CFR Part 820, titled “Quality System Regulation” (QSR). The requirements in Part 820 are the foundation for designing, manufacturing, and distributing medical devices in a manner compliant with the FDA requirements. Part 820 includes the mandatory minimum requirements for designing, manufacturing, and distributing any product identified as a medical device.

This course includes a multiple-choice quiz at the end, which is designed to enhance the understanding of the course materials.


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NY PE & PLS: You must choose courses that are technical in nature or related to matters of laws and ethics contributing to the health and welfare of the public. NY Board does not accept courses related to office management, risk management, leadership, marketing, accounting, financial planning, real estate, and basic CAD. Specific course topics that are on the borderline and are not acceptable by the NY Board have been noted under the course description on our website.

AIA Members: You must take the courses listed under the category "AIA/CES Registered Courses" if you want us to report your Learning Units (LUs) to AIA/CES. If you take courses not registered with AIA/CES, you need to report the earned Learning Units (not qualified for HSW credits) using Self Report Form provided by AIA/CES.

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