medical device quality management News
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Hyalex Receives ISO 13485 Certification
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 management system. It brings Hyalex one step closer to the clinic and patients who may benefit from the HYALEX Cartilage System. ...
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SteriLux has received ISO 13485:2016 certification
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 medical device industry. “We are very proud to have received this certification ...
By SteriLux SA
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STEMart Launches Microbiology & Sterility Testing Services for Medical Devices
STEMart, a provider of integrated medical device CRO services dedicated to medical device and diagnostic clinical development, introduces comprehensive microbiology and sterility testing for sterile, non-pyrogenic products. STEMart has extensive expertise in microbiology as well as sterility testing and remains dedicated to a full-service experience that supports manufacturers in meeting ...
By STEMart
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Exsomed Corporation Announces Completion of MDSAP Certification and ISO 13485:2016 Audit With Zero Findings
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 for one regulatory audit of a medical device manufacturer’s ...
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Renishaw opens dedicated healthcare facility at its South Wales site
Global precision engineering company Renishaw plc has announced a new Healthcare Centre of Excellence at its Miskin site, located close to Cardiff, South Wales. 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 ...
By Renishaw plc
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MicroLyte Vet Now Available in Canada
Imbed Biosciences is proud to announce that its animal health product, MicroLyte® Vet, is now available in Canada through McCarthy and Sons Service. McCarthy & Sons Service is a full-service veterinary marketing, supply, and distribution company. Their team of distribution representatives are well versed in surgical and wound care products, and has experience bringing ...
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Imbed Biosciences Wins a $2M Award From the U.S. Army to Prevent Combat Wound Infections
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 biofilms. The contract ...
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Microlyte SURGICAL Associated with Positive Outcomes in Prospective Clinical Case Series in Patients at Risk for Surgical Site Infection
Imbed Biosciences, Inc. (Imbed), a privately held biotech company emerging as a leader in advanced wound care, announced today the results of a prospective clinical evaluation of its next-generation wound Matrix, Microlyte® SURGICAL, in diabetic patients undergoing foot and ankle surgery who would ordinarily be at risk of a surgical site infection. Results will be published in the October ...
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