Last year the date of application (end of transition) of the EU Medical Device Regulation (EU MDR) was extended as the COVID pandemic gripped the world. It appears that this time around there will be no further extensions and if you haven’t finished your transition work, you are probably in a panic to get this done and may not know where to start.
Alongside this is the continued transition for the in vitro diagnostic manufacturers from the IVDD to the IVDR. This transition is unlikely to be moved and is a much bigger transition than the EU MDR.
This half day virtual workshop will focus your attention on the critical aspects of your quality management system that are needed to support compliance with the European Regulations (EU MDR/IVDR) with examples provided to help understand the actions to be taken. The core information covered will be:
• Post market surveillance reports (PMSR & PSUR)
• Clinical Evaluation/Performance Evaluation Reports (CER/PER)
• Roles of economic operators (additional responsibilities of your authorized representative and others)
• Role of the Person Responsible for Regulatory Compliance (PRRC) within your organization
• Technical Documentation
• Required coordination with your Notified Body
• Other Quality Management System (QMS) requirements
Cost: $50 for ASQ members. $60 for non-members
Registration link: https://my.asq.org/communities/events/item/317/60/2433
Registration closes Wednesday, December 10, 2020 @ 6am
ABOUT OUR PRESENTER
Mark Swanson (ASQ CMQ/OE, CQE, CBA) is the President and lead consultant of Quality and Regulatory Expert Partners, LLC; a partnership focused on helping small to mid-sized companies have the same regulatory and quality systems knowledge as the large medical device companies. Mark has more than 20 years of experience in the medical device industry including all roles in quality. He is a senior member of ASQ, RAPS member and a corporate AAMI member (serving on several AAMI committees).
Mark has spent the last several years as an active member of ISO Technical Committee 210 (ISO TC210), Working Group 1 (WG1) working on the revision of ISO 13485 that was published on March 1, 2016, was the project co-lead for the guidebook on ISO 13485 and Working Group 6 (WG6) on post-market surveillance (ISO TR 20416). He has also participated with ISO TC176, WG24 on ISO 9000/9001:2015 and in the AAMI group responsible for TIR 102, to formally compare ISO 13485 to the US FDA Quality System Regulation. To add to this, Mark also participated in the US TAG for risk management (ISO 14971) and the workshop that created IWA 31 (agreement on the application of risk management in standards). In this work he leads the 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 management system.