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Iso 13485 2016 Certificate 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 ...
Ended the Year With $55 Million in Cash Expected To Fund Operations Through the End of 2024 Including Release of Topline Pivotal Trial Data Nine (9) VenoValve Surgeries Successfully Completed and 16 Clinical Sites Currently Active in Ongoing SAVVE U.S Pivotal Trial Continued Advancement in Development of Second Device for the Treatment of Venous Disease Expected To Be Unveiled in Mid-2022 ...
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; ...
Daxor Corporation (Nasdaq: DXR), the global leader in blood volume measurement technology, today issued a corporate update in a Letter to Shareholders filed in its certified shareholder report on Form N-CSR on February 28, 2022 from CEO & President, Michael Feldschuh. Dear Fellow Shareholder: It is not every day you get to walk into Times Square in New York City and see your face and ...
BrainScope®, a medical neuro-technology company focused on concussion and mild traumatic brain injury (mTBI) assessment, announced today that it had concluded both algorithm development and clinical validation studies in adolescent and young adult populations using its objective, EEG-based technology. The purpose of the studies was to create and validate an objective, personalized capability ...
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; ...
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; ...
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. The CE Marking is intended for deXtreme, our upper limb neurorehabiliatation robotic device, meant to treat stroke and other TBI patients with our novel Error Enhancement technology. By this CE Marking we ...
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 ...
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 ...
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 applies proprietary non-invasive electrical ...
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 ...
BrainScope®, a medical neuro-technology company focused on concussion and mild traumatic brain injury (mTBI) assessment, announced today that researchers have published preliminary results related to a multi-modal concussion assessment capability for potential severity and likelihood of prolonged recovery from concussions. Published in the peer-reviewed journal Computers in Biology and ...
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. ...
BrainScope®, a medical neuro-technology company focused on concussion and mild traumatic brain injury (mTBI) assessment, announced today that it has received FDA clearance to include additional language in its product’s Indications for Use (IFU), adding key terminology related to “multi-modal, multi-parameter assessment" of “concussion" and “mild Traumatic Brain ...