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Iso 13485 Medical Device Articles & Analysis
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We are happy to announce that Hyalex Orthopaedics has received ISO 13485:2016 certification for Medical Device and Quality Management Systems. ...
Imbed Biosciences, Inc. announced today that it has been awarded a contract for $1,999,481 by the U.S. Army Medical Research and Development Command’s (USAMRDC) Military Infectious Diseases Research Program (MIDRP) to accelerate clinical development of an antibiofilm version of its next-generation Microlyte® Matrix wound dressing that can kill bacteria hidden in ...
Imbed Biosciences is proud to announce that research conducted using Microlyte Matrix and Microlyte Surgical will be presented in a panel discussion at SAWC, a national wound healing conference. Imbed Biosciences announced today that clinical results documenting the use of its products, Microlyte® Matrix and Microlyte® SURGICAL, will be presented at the Fall Symposium on Advanced Wound ...
Imbed Biosciences Inc. is a privately held biotech company registered with the FDA as a medical device manufacturer with an ISO 13485 certified quality management system. ...
Originally founded in 1970 as Applied Fiberoptics Inc., AFI was one of the first companies to produce glass fiber imaging for use in surgical device illumination. With the acquisition in 1996 of Schott Fiber Optics’ flexible endoscope division, medical and industrial endoscopes were added to the product portfolio. ...
Maintaining this focus enables the company to provide faster assembly operations than those in large factories. Computrol maintains its ISO 9001-2008 certification, ISO 13485 specific to medical device quality systems, AS9100 specific to military and aerospace quality systems, IPC class II and III and J-Std ...
Biomatlante, a world leader in synthetic bone regeneration technologies, is pleased to announce the obtention of the MDSAP* accreditation on the new ISO 13485:2016 Certificate. The Medical Device Single Audit Program (MDSAP) is an international program for assessing the quality management systems of medical ...
V. that the Company’s management system meets the requirements of EN ISO 13486:2016. This internationally agreed standard sets out the requirements for a quality management system specific to the medical devices industry. ISO 13485:2016 is designed to respond to the latest quality management system ...
We are excited to announce that SteriLux has received ISO 13485:2016 certification for Medical Device and Quality Management Systems from Lloyd’s Register. This ISO certification indicates that the company’s quality management system meets the most current regulatory requirements specific to the ...