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Class Iii Ce Certified Medical Devices Articles & Analysis
9 news found
Many medical devices are manufactured through plastic injection moulding, which allows for precise and top-quality components in large-scale production and better aligns with ISO standards. In general, injection moulding for medical devices is conducted in an ISO 8 clean room environment to ensure all products adhere to the strictest standards of sterility and safety.This article covers how ...
STEMart, a US-based provider of comprehensive services for all phases of medical device development, announces the expansion of its medical device testing capabilities and introduces Balloon Catheter Testing Services for the development of safe and effective medical devices. These reliable testing solutions will meet the evolving needs of the medical device industry and help manufacturers ...
BySTEMart
IRVINE, CA / August 16, 2022 / enVVeno Medical Corporation (NASDAQ:NVNO) (“enVVeno” or the “Company”), a company setting new standards of care for the treatment of venous disease, today announced the appointment of Kevin Belteau as Vice President of Clinical Operations. Mr. Belteau joins enVVeno Medical following a twenty-three-year career in clinical operations at ...
Healthium Medtech Limited (“Company” or “Healthium Medtech”), a global medical devices company focused on surgical, post-surgical and chronic care, today announced the launch of its latest manufacturing facility in Ahmedabad. The facility owned by Uteshiya Medicare, is located at the Rohisa Industrial Estate, and has been licenced by ...
Mundomedis recently acquired 96% of the common shares of US-based medical device manufacturer, Tennessee Medical Innovations Inc. (TNMI). TNMI will serve as Mundomedis’ platform for further medical device investments and acquisitions which Mundomedis is currently evaluating. Besides the financial investment, TNMI will benefit from Mundomedis’ global sales & marketing ...
ClaroNav Kolahi Inc (CKI) is pleased to announce that it has received Health Canada approval for its Navient ENT and Navient Cranial as Class III medical devices. Previously both devices had been approved as Class II devices. “Navient is one of the very few image guided navigation systems approved by Health Canada as a Class III device. Upgrading our license to a higher class demonstrates ...
ByClaroNav
BlueWind Medical announced today that enrollment has commenced at U. S. sites in the Pivotal Clinical Trial of the RENOVA iStim™ implantable tibial neuromodulation System (RENOVA) for the treatment of Overactive Bladder (OAB) following conditional Investigative Device Exemption (IDE) approval by the U.S. Food and Drug Administration (FDA). There are approximately 40 million adults in the ...
Human Life CORD Japan, Inc., (HLC) a group company of Nihon Trim (Cord No. 6788, Tokyo Stock Exchange 1st Section) is pleased to announce a strategic agreement with Tissue Genesis, LLC (TG) to distribute its proprietary stem cell processing products in commercial clinics, research institutions, and hospitals in Japan and China. The 10-year agreement marks a major leap forward in advancing the ...
BSI, a world-class Notified Body providing regulatory and quality management reviews and product certification for medical devices, today announced the launch of CE-Dedicated FastTrack. This new CE marking program is designed to help medical device manufacturers get their products quickly and safely to European markets. BSI will debut the program at the 2009 Regulatory Affairs Professionals ...