Omnex Resource Center

The presentation will discuss who the IMDRF is what they do and the developments in the industry with the FDA on the Cybersecurity forefront. It will also discuss some of the frequently asked questions when considering Cybersecurity with new submission and what can be expected now.

Publish Date:November 14, 2023

Medical Devices are increasingly connected in networks, cloud and to the internet.

Publish Date:November 10, 2023

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

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