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Medical device manufacturers, notified bodies, and the pharmaceutical industries involved in a single integral drug-device combination product's development must be aware of the impact of the Medical Device Regulation Article 117.
This webinar will explore what will change when MDR is applicable, the most recent experience with the new obligations, and essential steps to obtain a Notified Body Opinion.
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The impacts of Article 117 on the product portfolio
Essential safety and performance requirements
How to prepare documentation for the first submission
Change Management concepts applied for medical devices
Ms. Julia Frese
Division Head of Medical Services and Health Services, TÜV SÜD Japan
Julia is a biomedical engineer with a Master degree in Business Administration. Julia gained experience in development, regulatory approval of combination devices and ATMP products. She was also involved in the development of standards for ATMP products.
Currently, Julia is heading the division of Medical and Health Services at TÜV SÜD Japan and is responsible for the development of Article 117 service within the organization. She is also the co-chair of Team NB working group for Article 117.
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Bosnia and Herzegovina