(IN BRIEF) Mindray has received EU MDR Notified Body Certificates for three core surgical products—Articulating Endoscopic Linear Cutter and Reloads, Polymer Ligation Clip, and Reusable Electrode Surgical Instruments—awarded by TÜV Rheinland Greater China on July 11, 2025. This certification marks … Read the full press release
Posted in Business, Financial, Germany, Government, Healthcare, Industrial, Investment, Management, Marketing, News, Security & Safety, Technology
Tagged 2025 certifications, Articulating Endoscopic Linear Cutter, CE marking, Chinese medical devices, clinical safety, EU market access, EU MDR, Global Expansion, Hangzhou Mindray Medical Technology, healthcare manufacturing, INNOVATION, ISO 13485, IVDR, MDSAP, medical device certification, Mindray, minimally invasive surgery, Nanjing, partnership, Polymer Ligation Clip, R&D, regulatory compliance, Reusable Electrode Surgical Instruments, Shao Lingyun, Tony Chen, TÜV Rheinland, Wang Wenlong, Wendy Geng, Zhang Haifeng, Zuo Pengfei
(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
(IN BRIEF) SGS Belgium NV has been officially designated by the European Commission and Belgian Competent Authority as a Notified Body (NB) under the In Vitro Diagnostic Medical Device Regulation (IVDR), EU 2017/746. This milestone enhances SGS’s ability to support … Read the full press release
Posted in Belgium, Business, Financial, Healthcare, Industrial, Investment, Management, News, Science, Switzerland, Technology
Tagged Belgium, certification, compliance, EU, EU IVDR, FAGG/AFMPS, Geofrey De Visscher, In Vitro Diagnostic, ISO 13485, IVDR, MDSAP, medical device, Medical Device Regulation, Notified Body, partnership, patient care, Regulation, SGS, UKCA
(IN BRIEF) SGS Belgium NV has been designated as a Notified Body under the EU’s In Vitro Diagnostic Medical Device Regulation (IVDR), expanding Europe’s limited capacity for regulatory assessments. Approved by the European Commission and Belgian authorities, the Antwerp-based facility … Read the full press release
Posted in Belgium, Business, European Union, Financial, Government, Healthcare, Industrial, Investment, Management, News, Switzerland, Technology
Tagged AFMPS, CE compliance, CE marking, diagnostics, EU 2017/746, EU regulatory compliance, European Commission, FAGG, Geofrey De Visscher, in vitro diagnostic medical devices, ISO 13485, IVDR, IVDR certification services, MDR, MDSAP, medical device certification, NANDO database, Notified Body 1639, partnership, patient safety, regulatory affairs, SGS Antwerp, SGS Belgium, UKCA
(PRESS RELEASE) KFAR SABA, Israel, 9-Nov-2021 — /EuropaWire/ — Origami, a leading provider of no-code business process automation software for Medical Device and other industries, and citoQualis, a regulatory and business advisory leader for EU Medical Device companies, are announcing … Read the full press release
Posted in Healthcare, News, Pharma & Biotech
Tagged Amanda Brewster, business process automation, cGMP, citoQualis, EU MDR, EU regulatory, EU regulatory updates, GMP, GROWTH, ISO 13485, ISO 9001, IVDR, Life Science, Market Access, MDSAP, medical device, origami, patient safety, Pharmaceutical, QMS, Quality Management, Regulation (EU) 2017/745, Regulations, regulatory compliance, supply chain, US, Wolfgang Werner, Yaniv Shimony
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