Showing results for: ISO 13485 medical device News
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Scion Medical Technologies Receives ISO 13485 Certification
Newton, MA– Scion Medical Limited was awarded ISO 13485 certification both for its China manufacturing facility in Taizhou, China and for its US subsidiary, Scion Medical Technologies LLC. ISO 13485 is an internationally recognized quality standard for medical devices. ISO 13485 represents the requirements for a comprehensive quality management system for the design and manufacture of ...
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Fibralign receives ISO 13485:2016 upgrade certification
Fibralign received Certification Notification on January 21, 2019 from DEKRA Certification B. 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 ...
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Optim LLC celebrates 50 Year Anniversary of Optical Imaging Excellence
Optim LLC, a leading manufacturer of proprietary portable flexible endoscopes and videoscopes for use in the visual diagnosis of Ear-Nose-and-Throat (“ENT”) disorders, contraband detection equipment as well as components for the Ultrasound market, announced today the company is celebrating a major milestone with 50 years in the optical imaging industry. Originally founded in 1970 as ...
By Optim LLC
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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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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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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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Learn About Computrol’s Rapid Prototyping Capability at APEX
Computrol, Inc., a world-class provider of mid- to low-volume, high-mix electronic manufacturing services to OEMs, will exhibit in Booth #1640 at the 2020 IPC APEX EXPO, scheduled to take place Feb. 4-6, 2020 at the San Diego Convention Center in California. The company has continuously upgraded its state-of-the-art manufacturing facilities over the past three years. The company most recently ...
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Biomatlante receives MDSAP Accreditation
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 device manufacturers who market their products in Australia, Brazil, Canada, Japan and/or ...
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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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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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dBMEDx™ , Inc. Announces CE Mark for BBS Revolution™ Bladder Scanner
dBMEDx, Inc., a privately-held, wireless medical device company, announced today that it has received the CE Mark for the BBS Revolution™, a next generation bladder scanner which offers, for the first time, fully automated bladder detection and unparalleled ease of use, speed and accuracy for the non-invasive measurement of bladder volume. This product is currently FDA cleared and is being ...
By dBMEDx
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NSF International First to Offer High Quality Secondary Reference Standards to India’s Growing Pharmaceutical Sector at Lower Cost
NSF International, an independent global public health and safety organization which develops standards, and tests and certifies products for the pharmaceutical, dietary supplement, food, water, and consumer products industries, is the first to offer Secondary Reference Standards in India, helping meet the growing India pharmaceutical sectors’ need for high quality, economical alternatives ...
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Microlyte Matrix and Microlyte Surgical featured in clinical research presented at SAWC
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 ...
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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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