(IN BRIEF) DNV has partnered with Korean diagnostics company Noul to certify its AI-powered malaria, blood cell and cervical cancer testing solutions under the EU In Vitro Diagnostic Medical Device Regulation. Acting as an IVDR Notified Body, DNV will assess … Read the full press release
Posted in Artificial Intelligence (AI), Business, Healthcare, Industrial, Management, News, Norway, Pharma & Biotech, Technology
Tagged AI diagnostics, blood cell morphology, CE marking, Cecilie Gudesen Torp, cervical cancer testing, diagnostic technology, DNV, DNV and Noul Collaborate to Advance EU Certification for AI-Powered Medical Diagnostics, DNV to Support IVDR Certification of Noul’s miLab Diagnostic Platform, EU Medical Device Regulation, Healthcare Innovation, in vitro diagnostic devices, IVDR certification, malaria diagnosis, medical device certification, miLab platform, Noul, point of care diagnostics, Taehwan Kim
(IN BRIEF) TÜV Rheinland Greater China has issued EU MDR Notified Body Certificates to three key Mindray surgical devices—the Articulating Endoscopic Linear Cutter and Reloads, Polymer Ligation Clip and Reusable Electrode Surgical Instruments—during a July 11, 2025 ceremony in Nanjing. … Read the full press release
Posted in Business, Germany, Government, Healthcare, Industrial, Investment, Management, Marketing, Media, News, Security & Safety, Technology
Tagged Articulating Endoscopic Linear Cutter, Brazilian INMETRO, carbon of strategic partnership, Chinese medical devices, clinical evaluation, design and development, EU market access, EU Medical Device Regulation, global strategy, Hangzhou Mindray Medical Technology, international collaboration, ISO 13485, IVDR, MDR Notified Body Certificates, MDSAP, medical device testing, Mindray, minimally invasive surgery, partnership, Polymer Ligation Clip, post-market surveillance, Quality Management, regulatory compliance, Reusable Electrode Surgical Instruments, Shao Lingyun, Tony Chen, TÜV Rheinland Greater China, TÜV Rheinland services, Wang Wenlong, Wang Xinbing, Wendy Geng, Zhang Haifeng, Zuo Pengfei
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