The MDR implementation last May has highlighted issues within the industry that need to be addressed and the upcoming IVDR updates will have a profound impact on the medical device industry, bringing certain products into regulatory scope that were previously excluded, introducing new manufacturing requirements, and increasing the burden for post-market surveillance.
The conference will provide insight into the latest updates in EU MDR and IVDR regulations and will discuss strategies for how to best comply with these regulations. In addition, the conference will consider the evolving regulatory landscape for digital health software.
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