Webinar Features

IVDR Transition for Class B IVDs: What a Notified Body Looks For, and Best Practices for Technical Files 

Access the on-demand webinar to learn how Class B IVD manufacturers can build proportionate clinical evidence, meet IVDR documentation and Notified Body expectations, and navigate conformity assessment with confidence ahead of the 26 May 2027 transition deadline.
Format

On-Demand Webinar

Level

Intermediate

Trainer

Kristiane Schmidt and Heike Möhlig-Zuttermeister (BSI)

Exam

Certificate of Participation included

Duration

1 hour

Price

Free

Comprehensive Regulatory Expertise

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Flexible Viewing

Gain insights from industry experts and stay updated on the latest trends and regulations without the need to attend live sessions.

Access to Expertise

Meet the Trainer

Kristiane Schmidt

Kristiane is a senior consultant at Qserve Group with over 15 years of expertise in IVD product development, ISO & CE marking, risk management, and clinical trials, leveraging her strong technical background and passion for advancing medical technologies.