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Does Quality System Meet EU MDR Requirements Webinar

This webinar was presented by Dr. Eamonn Hoxey of E V Hoxey Ltd and Mark Swanson, R&Q's Executive Director, Intelligence and Technical Excellence.

New EU regulations for medical devices come into full application by May 2020. The parallel regulations for IVDs apply from 2022. This particularly affects those organizations that may have not been previously been subject to regulation (e.g., distributors, importers) and those for whom the regulatory requirements have increased (manufacturers, authorized representatives). Medical device organizations must have an adequate quality management system in place to maintain access to the EU market and other markets that recognize EU authorizations. They need to designate a person that is responsible for regulatory compliance with defined responsibilities. The interactions of organizations in the supply chain need to be managed within a quality management system.

This webinar will provide you the information to determine the requirements for your organization and the steps you need to be taking to ensure compliance before the date of application in 2020/2022.

Audience: Quality and Regulatory professionals, Executive Management, Legal, in Manufacturers, Distributors, Importers, Authorized Representatives

About the presenters

Eamonn Hoxey Regulatory and Quality SolutionsEamonn Hoxey is a technical author, trainer, and consultant on a range of life science areas including regulatory compliance, quality management, sterility assurance and standards development. Eamonn worked for Johnson & Johnson for 17 years in positions of increasing responsibility for Quality and Regulatory Compliance for medical devices, pharmaceuticals and consumer products including VP of Compliance, VP of Market Quality, and VP of Quality & Compliance Strategic Programs leading quality implementation for the EU medical devices regulation for J&J’s Medical Devices companies. Prior to joining J&J, Eamonn spent 16 years with the UK Medical Devices Agency, including six years as Head of Device Technology and Safety.

Eamonn is currently chair of ISO TC 198, Sterilization of Healthcare products and past chair of ISO TC 210, Quality management and related general aspects for medical devices. He received the BSI Wolfe-Barry medal in 2016 for his contribution to standards development.

 

Mark Swanson, Mark Swanson Regulatory and Quality SolutionsExecutive Director, Intelligence & Technical Excellence

Mark is R&Q's Director of Minnesota Operations / Principal Consultant - and is also a member of ISO Technical Committee 210 (TC210) and Working Group 1 (WG1). Additionally, he is a member of the MDIC Case for Quality Forum. Mark (CMQ/OE, CQE, CBA) has spent more than four years as an active member of ISO Technical Committee 210 (TC210), Working Group 1 (WG1) working on the revision of ISO 13485:2003 that was published on March 1, 2016 and has also participated with ISO TC176, WG24 on ISO 9001:2015. This work includes discussions regarding the impact of changes in the ISO quality management system standards, the integration of various standards and how to effectively integrate these various international standards and other regulations into a single quality management system.