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Iso 13485 Requirements For 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. This certification is a regulatory requirement and international standard outlining requirements for a medical device ...
The contract was awarded through Medical Technology Enterprise Consortium (MTEC) for prototype solutions that prevent combat wound infections following blast injuries and burns. ...
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 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 ...
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 ...
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 ...
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 ...
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 ...