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Medical Device Risk Management 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 quality management system. It brings Hyalex one step closer to the clinic and patients who may benefit from the HYALEX Cartilage System. ...
HD Medical, Inc., the leader in cardiovascular disease detection, today announces that Michael Herring has joined the team as the US Vice President of Sales. Herring brings his 25 years of experience in medical device sales to the company, having previously worked for 3M, Cantel Medical, Nanosonics, and TSO3. Herring plans to leverage his unique background in medical device sales management and ...
BioVentrix, Inc., a privately held medical device company focused on treating congestive heart failure (CHF) via Transcatheter Ventricular Restoration (TCVR), today announced that heart failure specialist Jerry Estep, MD, of the Cleveland Clinic has been appointed co-principal investigator of the pivotal ALIVE Trial studying LIVE Therapy using the Revivent TC ...
BlueWind Medical, a medical device company developing minimally invasive neurostimulation devices, announced today the appointment of Kerry Nelson to the company’s Board of Directors. Nelson is a successful medical device investor and fund manager who has launched and managed healthcare focused investment funds. Over the course of her career, she has counseled public and private medical ...
Hughes brings more than 20 years of financial and operational experience in senior executive leadership positions in the medical device industry, successfully managing privately and publicly held enterprises and offering expertise in scaling companies globally, managing operations and finance, and successfully completing ...
BlueWind Medical announced today that enrollment has commenced at U. S. sites in the Pivotal Clinical Trial of the RENOVA iStim™ implantable tibial neuromodulation System (RENOVA) for the treatment of Overactive Bladder (OAB) following conditional Investigative Device Exemption (IDE) approval by the U.S. Food and Drug Administration (FDA). There are approximately 40 million adults in the ...
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 medical device industry. “We are very proud to have received this certification ...
Recently, the National Health Commission and the Ministry of Industry jointly held the conference to promote the development and application of domestic medical equipment, the domestic medical equipment upgrades once again become the focus. Miao Wei, Minister of Industry and Information, said that in order to promote the development of domestic medical equipment industry, will establish the ...
Recently the state food and drug supervision and administration bureau released five related medical devices regulations come into force as of June this year to the new revision of the regulations on the supervision and administration of medical devices, authorized by the state administration of the in-depth research, many times, ...
Medical Devices CE Marking: This course discusses the EU classification of medical devices, the European CE Marking approach, the quality assurance requirements for medical devices sold in Europe, and changes coming to MDD. The course will enable you to recognize the role of standards, essential ...