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十一月 22, 2023

PDF Download | Empowering MedTech Innovators: A Deep Dive into FDA's CDRH Innovation Initiatives

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十一月 22, 2023

On-Demand Webinar | Empowering MedTech Innovators: A Deep Dive into FDA's CDRH Innovation Initiatives

Watch our on-demand webinar ''Empowering MedTech Innovators: A Deep Dive into FDA's CDRH Innovation Initiatives.''
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十一月 22, 2023

Dancing with Non-device General Purpose Software | What to learn from MDCG 2023-4?

This blog post takes a new angle on MDCG 2023-4 and extends its key principles for the combination of MDSW with non-device general-purpose software.
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十一月 16, 2023

On-Demand Webinar | UDI - Navigating the implementation hurdles on a global scale

This free webinar covers the UDI allocation, data management and QMS considerations in terms of global UDI developments, complexities and differences.
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十一月 15, 2023

Clinical Evaluation of AI-assisted Diagnostic Medical Device Software in China – A new NMPA guidance

Explore the latest CMDE 2023 No. 38 guidance from China's NMPA, outlining expectations for AI-assisted diagnostic medical device software. Our blog offers a concise English summary, providing insights into crucial elements like clinical trial design, study subjects, evaluation metrics, and statistical considerations.
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