Navigating IVDR Compliance: How to Best Work with a Notified Body for an Efficient Transition

A Metecon webinar in collaboration with BSI Group

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Join us for a webinar aimed at IVD manufacturers seeking IVDR compliance.
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Don't miss out on this opportunity to learn and grow! We are excited to host this event in collaboration with BSI, where you will gain expert insights that will aid in your IVDR application.

Our guest speaker Charlotte Hess, Business Development Manager Regulatory Services for IVD at BSI, will present “The IVDR Application Process – What Do You Need to Know?” We are delighted to have Charlotte join us for this webinar.

Dr. Sandra Reuter, Senior Expert IVD at Metecon, will share her insights on “IVDR Implementation – Lessons Learned & Best Practices”, with a focus on how to make the most of the short IVDR transition period.

In the concluding Q&A session, we will answer your questions about the IVD application process and implementation.

This webinar is designed for professionals in quality management, regulatory affairs, and clinical affairs, and provides actionable strategies and essential insights to submit timely IVDR applications and implement strategies successfully.

The webinar is free of charge, and is conducted in English.​​​​​​​

Ready for IVDR compliance? Register now and join us!
We can't wait to have you on board!
Charlotte Hess, Regulatory Services Medical Devices at BSI

Charlotte is the Senior IVD Business Development Manager for Northern Europe at BSI and responsible for managing IVDR applications.

Her goal is to help manufacturers access the right information to navigate the complexities of the IVDR certification process and submit timely applications.  
Charlotte joined BSI in 2017 and has a wealth of knowledge and experience of the IVD industry. Whether starting the certification process, looking to transfer to another notified body, or just exploring options available, Charlotte has the answers.


Dr. Sandra Reuter, Regulatory Affairs IVD at Metecon

Sandra, Metecon's Senior Expert IVD, is well versed in finding the individual strategy for a smooth approval process for IVDs, which she then implements for her clients, the IVD manufacturers. 
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The perfect strategy in regulatory affairs is one that quickly and reliably achieves the goal and at the same time uses the available resources as efficiently as possible. These points are always on Sandra's checklist.
She has 15 years of experience in development and RA at an IVD manufacturer. Sandra's professional development since joining Metecon in 2020 has made her a key member of Metecon's IVD team: Sandra's dedication leads her clients' regulatory processes to success.

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