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Medical Device Quality Management 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. This certification is a regulatory requirement and international standard outlining requirements for a medical device quality ...
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 ...
“Our goal after publishing results on chronic wounds was to evaluate this antimicrobial matrix in the management of surgical wounds in at-risk patients” says Ankit Agarwal, PhD, co-founder and CEO of Imbed. ...
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. ...
ExsoMed Corporation, a privately held U.S.-based medical device company providing orthopaedic surgeons with innovative solutions in hand surgery, announced that it has successfully completed Medical Device Single Audit Program (MDSAP) certification and ISO 13485:2016 audits, with no open findings. MDSAP is a program that allows ...
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 ...
The Centre, which was formally opened on 29th September by The Rt Hon Carwyn Jones AM, First Minister of Wales, provides a facility for the manufacture of custom medical devices, as well as education and training for the life sciences community. ...