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Top Management’s Responsibility for Risk Management in Medical Device Manufacturing (The Requirements of ISO 14971:2019)
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.

We will begin with a brief introduction to the concept of Risk Management and why it has become an expectation, integral with every aspect of the Medical device life cycle. We’ll then move on to each clause and take a bird’s eye view of what the expectation is for your company’s Top Management.

We’ll also spend a few minutes on the Annex’s, and ISO 24971:2020 giving an overview of their value to Top Management’s development of risk management for medical device manufacturers.

May 12, 2021 11:00 AM in Eastern Time (US and Canada)

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Michael Checketts
Senior Manager & Certified Lead Auditor for ISO 13485:2016, ISO 14001:2015, ISO 17025:2017, and ISO 9001:2015 @Omnex Inc
Mr. Checketts has extensive experience in the Medical Device industry, and served as a Manufacturing Engineer & Engineering Manager for a major medical device manufacturer, where many products were successfully moved from R&D to manufacturing. Improvements in manufacturability became his forte. Michael transitioned into the Medical Device startup company environment and utilized these same techniques to provide superior manufacturability. Utilizing tools such as SPC, and verification/validation techniques (IQ/OQ/PQ, incorporating DOE and Process Capability) was key to his success. Michael has worked in all facets of engineering including the following disciplines: R&D, Design/Drafting, Product Development, Software Development, Industrial/Manufacturing Engineering, Machine/Tool Design, Rapid Prototyping, Tool & Mold Shops, and Facilities. In addition to his engineering expertise, Michael has extensive Quality/Regulatory experience in the Medical Device industry.