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Iso 13485 2016 Upgrade 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 mark and Medical Device Registration for the ...
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 ...
Autocam Medical, a global contract manufacturer of precision surgical and medical components and devices, announced Tuesday that they would be recruiting for a number of positions at the Montcalm Community College Job Fair on March 22nd. The company is looking to hire CNC Machinists, Manufacturing Engineers, and Secondary Operators that aspire to become Machinists. While the event is being held ...
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 ...
Autocam Medical announced Tuesday that after an outstanding 32-year career, Tom O’Mara, Executive Vice President, has notified the company of his intent to retire at the end of the 2022 calendar year. Although Mr. O’Mara will be slowly relinquishing full-time responsibilities, he will remain in an advisory role with the company beyond December 31, 2022. Mr. O’Mara began his ...
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. ...
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. The event, recognizing the company’s fourth class of graduates, was kicked off with a few ...
Autocam Medical, a global contract manufacturer of precision, surgical and medical components and devices, announced today that it is investing $60 million through 2024 to expand its manufacturing footprint and capability in West Michigan. This new facility will continue to serve its customers by making products that improve people’s health. This investment includes a new ...
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. This certification confirms that Oncomfort manages the design, manufacturing and distribution of its Digital Sedation™ medical device and its Sedakit™, in its quality ...
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 ...
Fibralign Corp., a Stanford spin-out and developer of therapeutic biomedical devices, today announced that it has received CE mark for its first product, the BioBridge Collagen Matrix. 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 ...
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 ...
Dynacare Launches JOINTstat® Testing in Canada Augurex is pleased to announce the launch of JOINTstat (14-3-3?) testing services through Dynacare, one of Canada’s largest and most established health solution companies with a dedicated mission to support healthy lives with commitment and care. This arrangement will make JOINTstat testing accessible to more patients and physicians ...
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 who market their products in Australia, Brazil, Canada, Japan and/or ...
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. ISO 13485:2016 is designed to respond to the latest quality management ...
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 ...