Navigating New Post-Market Requirements and Changes to QMS

by Sep 19, 2019Life Science

The Q1 Productions 12th Semi-Annual IVD Clinical & Regulatory Affairs Conference takes place October 22-23 in Alexandria, VA. The event features a wide array of expert presenters that will speak to crucial challenges within the industry. Dr. Julien Senac, Global IVD Director at TÜV SÜD and distinguished member of the speaking faculty will present during the EU IVDR Learning Module on day two. Read on to learn more about Dr. Senac, his background and what he plans to cover.

 

Can you please give a brief description of your job title and what that entails?

As global IVD director, my task is to develop the IVD field of TÜV SÜD worldwide in terms of business development as well as resource building. The IVD field covers certifications, but also testing, such as EMC, software and functional testing and training. On a day-to-day basis, I engage with our headquarters in Munich and the various IVD teams in other regions in Europe, America and Asia to measure the needs in the various areas and develop strategies to better answer them with a global approach. Currently, the major effort is focused on the preparation of EU IVDR transition and ensure a smooth process for us and our customers. For this, our teams are in constant contact with our clients to work together on a transition plan. We also work with new clients in search of a suitable Notified Body for their products.

 

Please share a short overview of your session “EU IVDR Learning Module: Part Two: Post-Market Requirements & Quality Management Systems.”

The new European regulation is more detailed and prescriptive than the current in vitro diagnostic directive. The intent of this session will be to discuss requirements introduced by the regulation related to the post market surveillance system, such as the periodic safety update report. In addition, we will focus on post market performance follow-up studies, which may impact all products as there is no grandfathering for currently CE marked devices.

This is also important as post market requirements will have to be enforced by May 26, 2022, even if products are placed on the market with valid IVDD certificates after that date. In addition, we will also cover the Quality Management System and present the convergence and divergence with the QMS standard ISO 13485:2016.

Lastly, we want this session to be interactive, so the goal will be to ensure that people will be able to ask all questions they may have regarding the regulation and those topics.

 

What do you hope participants will learn from your session?

We hope that participants will be able to have a better understanding of the changes in the quality management system and responsibilities of the organization in general and how to implement changes in their system in the most effective way possible.

Moreover, participants will be able to inform the decision maker in their company of the needs and requirements of manufacturers to be compliant with the regulation, as this EU IVDR will represent an entire company effort from top management to manufacturing lines and from design to marketing.

 

Why do you think it’s important for regulatory affairs professionals to attend the Q1 IVD Clinical & Regulatory Affairs Conference?

We are half-way through the transition period and the changes brought by the European Regulation are major for the IVD industry, so it is crucial for manufacturers, in particular, regulatory affairs professionals, to be clearly informed and prepared. The program developed by Q1 Productions does cover all aspects of the regulation and allows manufacturers to meet representatives of Notified Bodies and other partners. The exchange of experience and point of view will help any professional to provide more insightful information to whom they will advise.

Learn more about the Semi-Annual IVD Clinical & Regulatory Affairs Conference and reserve your spot today!

Natalie Zunker is a Content Marketing Associate for Q1 Productions, where she is responsible for campaign planning, content development and executing marketing projects for the life sciences, pharmaceutical and food and beverage industries.

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