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十月 19, 2023

2023 Qserve论坛回顾

Conference CRO Global Registration In-Vitro Diagnostics Medical Device Regulations Highlights

七月 04, 2023

One year IVDR – certification stress and why you need to act now

Blog by Kristiane Schmidt about the outcome of the Dutch RAPS chapter, focusing on the IVDR and the bottlenecks caused by about 10,000 IVD devices that still need to obtain IVDR certification.

CE Certification Clinical Data In-Vitro Diagnostics IVDR Notified Body Technical Documentation Highlights

结果

十一月 22, 2023

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

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.''

FDA In-Vitro Diagnostics Medical Device Regulations Highlights

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.

MDCG Medical Device Regulations Highlights

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.

Global Registration Medical Devices On-Demand Webinar QA/RA Regulatory Affairs Regulatory Compliance UDI Highlights

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.

AI Clinical Evaluation Medical Device Regulations NMPA Highlights

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