(IN BRIEF) DNV has confirmed that the revision of ISO 9001 is progressing, with the Draft International Standard now released for global ballot and review. The update, due for full publication in late 2026, introduces new leadership requirements for promoting … Read the full press release
Posted in Business, Energy, Gas & Oil, Financial, Industrial, Investment, Management, Marketing, News, Norway, Security & Safety, Technology
Tagged Annex A, climate change integration, DIS, DNV, Draft International Standard, ethical behaviour, IAF, International Accreditation Forum, ISO 9001, ISO revision 2026, leadership commitment, management system standards, opportunity management, Quality Management, risk management, Tor Gunnar Tollefsen
(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
(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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