Refine by
Iso 13485 Medical Articles & Analysis
10 news found
Senstech sensors can be found in a variety of applications in the medical field, such as infusion or insulin pumps, in cardiotocography or in devices for eye surgery. ...
We are happy to announce that Hyalex Orthopaedics has received ISO 13485:2016 certification for Medical Device and Quality Management Systems. ...
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 certified as well as ...
Mar. 19, 2019 --(BUSINESS WIRE)--Rex Medical, L.P., a medical device design and development company, today announced the successful completion of enrollment in the Revolution™ Peripheral Atherectomy System for Lower Extremity Peripheral Arterial Revascularization (REVEAL) IDE clinical trial. ...
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 ...
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 practices, including ...
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 ...
(BusinessWire, North Andover, Massachusetts), MindChild Medical, Inc. today announced that it has received ISO 13485:2003 certification for the design, development and manufacturing of its MERIDIAN family of non-invasive Fetal Monitors1,2,3,4 . ISO 13485:2003 certification precedes European pre-market submission ...
The course will enable you to recognize the role of standards, essential requirements, and labeling, and the value of post-market surveillance and vigilance. Medical Devices Risk Management: ISO 14971: This course is designed to provide participants with an understanding of the impact that ISO 14971:2007 has on the decision making process at ...