Implementing ISO 13485 & Global Medical Device Regulatory Requirements

by Michael B. Checketts,Antony John published on January 26, 2021

In the US, Medical Device Standards include 21 CFR 820, and ISO 13485:2016. Those marketing their products in Europe would add EU MDR’s, and possibly MDSAP. But, that is only the beginning. 21 CFR 820, and ISO 13485 are only the Good Manufacturing Practice (GMP) portions of the regulation, and the Quality Management System (QMS) requirements of the manufacturing standards. Where are the remaining requirements found and what do they involve?

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.

There are various standards within the Medical Device Sector of the industry that may lie outside of statutory regulations, but are extremely important, and if not followed will cause havoc in meeting regulations. What are they and where can they be found?

We’ll also spend some time reviewing some “best in practice” methods to implement these regulatory standards and how best to control them. Although we won’t be going “in-depth” into any of the regulation areas, we’ll spend time reviewing ways to implement and control your QMS at the same time.


Antony John

Antony John is the Vice President of Omnex Systems. He has 19 years of experience transforming technology businesses across global markets and different customer industry segments, for profitable growth. Antony also possesses strong experience working in the Information Technology, Automotive, Aerospace, Oil & Natural Gas, and Insurance industries. He currently leads the Product Development of EwQIMS, a revolutionary software solution for managing Enterprise Quality for APQP, Integrated Management Systems / QHSE, and Supplier Quality used by Fortune 500 companies, OEMs, top automotive manufacturers, and large semi-conductor organizations across the globe.