Omnex Resource Center

21 CFR 820 contains the FDA requirements for Quality Management Systems (QMS). These requirements have been established since July 1978.

Publish Date:April 19, 2024

The webinar will provide an overview of the international quality management system standard for medical devices. Organizations may elect to have their management system the third party certified to this Standard to demonstrate competency in the fundamentals of quality management and to provide for

Publish Date:August 26, 2021

This webinar is intended to be an overview, or an executive summary, of what Risk Management entails. It is written for Medical Device Manufacturing Top Management and explains what is expected of them throughout the Risk Management process.

Publish Date:May 12, 2021

This webinar will be taking a “birds-eye-view” of what additional parts of 21 CFR are, as they apply to Medical Device Manufacturing, and also will look at the corresponding articles of the (EU) MDR’s.

Publish Date:January 26, 2021

Watch this important webinar recording for medical device organizations as we explain the MDSAP Framework, process approach, and the primary and supporting processes.

Publish Date:June 26, 2020

Omnex Webinar: An overview of the ISO 14971 Risk Management for Medical Device Quality Management System webinar is also be considered an executive summary of what Risk Management entails for your top management, and begins with a brief introduction to the concept of Risk Management.

Publish Date:May 22, 2020

ISO 14971 is an ISO standard for the application of risk management to medical devices and it was recently revised in 2019. Watch Webinar

Publish Date:March 10, 2020