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Iso 13485 Certification Articles & Analysis
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CardioWise, Inc., is pleased to announce that Perry Johnson Registrars, Incorporated has audited the CardioWise Quality Management System (QMS) and determined CardioWise is in conformance with ISO 13485:2016. Perry Johnson Registrars Certificate C2022-02910 was issued July 16, 2022, and represents the first step in the process of obtaining a CE ...
Recent Highlights Successfully completed 9 VenoValve surgeries and 16 sites currently activated in the Company’s SAVVE U.S. pivotal trial for the VenoValve; Presented positive long-term VenoValve first-in-human data at the 34th Annual Meeting of the American Venous Forum; Announced publication of one-year VenoValve data in the peer-reviewed journal,Vascular and Endovascular Surgery;and ...
They offer a value-added approach to high-precision manufacturing with specialties in CNC milling, turning and cutter grinding. The company has achieved ISO 13485:2016 certification and is an FDA registered facility. In addition to their facilities in Kentwood, Michigan, Autocam Medical has operations in Murfreesboro, Tennessee; Plymouth, ...
Our fully owned 20,000 square foot research and production facility achieved the valuable ISO 13485 certification in February of 2021 and provides a highly efficient center for both R&D and production. ...
BrainScope has received seven FDA clearances and ISO 13485 Certification. It has 26 peer-reviewed publications on its technology. ...
They offer a value-added approach to high-precision manufacturing with specialties in CNC milling, turning and cutter grinding. The company has achieved ISO 13485:2016 certification and is an FDA registered facility. In addition to their facilities in Kentwood, Michigan, Autocam Medical has operations in Murfreesboro, Tennessee; Plymouth, ...
We are happy to announce that Hyalex Orthopaedics has received ISO 13485:2016 certification for Medical Device and Quality Management Systems. ...
Autocam Medical, a global contract manufacturer of precision surgical and medical components and devices, presented 11 students with certificates of completion for their CNC Machinist Apprentice Program during a November 10th ceremony at the AMP Lab at Western Michigan University in Grand Rapids. ...
They offer a value-added approach to high-precision manufacturing with specialties in CNC milling, turning and cutter grinding. The company has achieved ISO 13485:2016 certification and is an FDA registered facility. In addition to their facilities in Kentwood, Michigan, Autocam Medical has operations in Murfreesboro, Tennessee; Plymouth, ...
ncomfort, the leader in Digital Sedation™, a digital therapy to relieve patient anxiety and pain, today announces that it has obtained the ISO 13485:2016 certification by certification company DARE!! Services. ...
BioXtreme is proud to announce that, following our ISO-13485 certification from the Israeli Standards Institution (www.sii.org.il), it has received its CE Marking, based on self declaration. ...
BioBridge is classified as a Class III device with an indication for use to support lymphatic tissue repair and can be used after or in conjunction with surgical procedures addressing lymphedema. CE mark is a certification symbol in Europe that signals conformity to patient safety and device performance standards applicable in the region. The certification mark ...
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 ...
Read More Augurex Commitment to Quality: ISO 13485:2016 Augurex is proud to announce its ISO 13485:2016 Certification. ...
Liberate Medical, a medical device company developing novel non-invasive electrical muscle stimulation devices to help patients with pulmonary conditions, today announced that it has received CE marking for its VentFree™ Respiratory Muscle Stimulator and ISO 13485 certification for its quality management system. The VentFree stimulator ...
EaglePicher Technologies has named Christopher W. Huntington as the new division president of EaglePicher Medical Power. He will also serve as a senior vice president of the parent company. Huntington brings 18 years of global experience in the medical device industry. He has held leadership positions in the United States, Europe and Asia spanning general management, business development, ...
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 ...
BrainScope has received six FDA clearances and ISO 13485 Certification. It has 26 peer-reviewed publications on its technology. ...
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 ...
BrainScope has received six FDA clearances and ISO 13485 Certification. It has 25 peer-reviewed publications on its technology. ...