medical device management News
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Hyalex Receives ISO 13485 Certification
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. ...
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Two ministries support the domestic medical equipment and will establish incentive mechanism
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 ...
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The state drug administration issued five medical devices regulations
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, on the basis of demonstration, solicit opinions from all sides, and ...
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SteriLux has received ISO 13485:2016 certification
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 ...
By SteriLux SA
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BlueWind Medical Strengthens Board of Directors with appointment of Kerry Nelson
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 ...
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Michael Herring Joins HD Medical as US Vice President of Sales
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 ...
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STEMart Launches Microbiology & Sterility Testing Services for Medical Devices
STEMart, a provider of integrated medical device CRO services dedicated to medical device and diagnostic clinical development, introduces comprehensive microbiology and sterility testing for sterile, non-pyrogenic products. STEMart has extensive expertise in microbiology as well as sterility testing and remains dedicated to a full-service experience that supports manufacturers in meeting ...
By STEMart
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V-Wave Announces appointment of Bill Hughes as Chief Financial Officer
V-Wave Ltd., a cardiovascular device company developing proprietary, minimally invasive interatrial shunt devices for treating patients with severe symptomatic heart failure (HF) and pulmonary arterial hypertension (PAH), announced the appointment of Bill Hughes as its Chief Financial Officer (CFO) today. “We are thrilled to add someone with Bill’s talent and experience to the V-Wave ...
By V-Wave Ltd.
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BSI group America Inc. Announces specialized regulatory training courses for the healthcare industry
BSI Group America Inc., a leading provider of total solutions for certification and standards announces the launch of Specialized Regulatory Training courses targeted specifically for the medical device industry. Available on-site, these Specialized Regulatory Courses reflect requirements of the latest amendments to the Medical Device Directive enabling attendees to comply efficiently with ...
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BioVentrix Announces Jerry Estep, MD, as Co-Principal Investigator for ALIVE Pivotal Trial Studying a Transcatheter Device for Heart Failure
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 TransCatheter Ventricular ...
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BlueWind Initiates U.S. Enrollment in Clinical Trial of the RENOVA iStim to Treat Overactive Bladder
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 ...
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dBMEDx™ , Inc. Announces CE Mark for BBS Revolution™ Bladder Scanner
dBMEDx, Inc., a privately-held, wireless medical device company, announced today that it has received the CE Mark for the BBS Revolution™, a next generation bladder scanner which offers, for the first time, fully automated bladder detection and unparalleled ease of use, speed and accuracy for the non-invasive measurement of bladder volume. This product is currently FDA cleared and is being ...
By dBMEDx
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Biomatlante receives MDSAP Accreditation
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 ...
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Exsomed Corporation Announces Completion of MDSAP Certification and ISO 13485:2016 Audit With Zero Findings
ExsoMed Corporation, a privately held U.S.-based medical device company providing orthopaedic surgeons with innovative solutions in hand surgery, announced that it has successfully completed Medical Device Single Audit Program (MDSAP) certification and ISO 13485:2016 audits, with no open findings. MDSAP is a program that allows for one regulatory audit of a medical device manufacturer’s ...
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WellAir Announces Appointment of Brad Niemann as Executive Vice President of Healthcare
WellAir, a leader in delivering clean air solutions to people around the world, today announced the appointment of Brad Niemann as Executive Vice President of Healthcare, to help drive the Company’s commercial growth within the global healthcare sector. "We are pleased to have Brad join our leadership team as we continue to strengthen our commercial and business strategies within ...
By WellAir
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Inceptus Announces Completion of Series B Financing for Okami Medical
Inceptus Medical LLC, a medical device company incubator, announced today that it has completed a $4.5M Series B financing for Okami Medical Inc. The financing will provide the resources to develop and commercialize innovative devices for the interventional treatment of cardiovascular disease. The financing was led by members of the board of directors, U.S. Venture Partners (USVP) and medical ...
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Avelas Welcomes Susan Stimson to its Board of Directors
SAN DIEGO, November 22, 2019 – Avelas Biosciences, Inc., a clinical-stage oncology company developing AVB-620 for real-time cancer detection is pleased to announced the addition of Susan Stimson as a Director of the company. “Susan brings an exceptional background and skillset to the Avelas Board. She has had incredible success throughout her career and her knowledge and experiences ...
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InnovHeart raises $55 million in Series C financing to further develop the Trans-septal Saturn Transcatheter Mitral Valve Replacement System
Milan, January 27, 2022 – InnovHeart s.r.l., a developer of novel Transcatheter Mitral Valve Replacement (TMVR) systems for the treatment of mitral valve disease, announces the closing of its Series C financing with granting an exclusive licensing agreement to Grand Pharmaceutical Group Limited, (Grand Pharma) for its proprietary Saturn device in Greater China. The transaction pulled in ...
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Quasar Medical Announces Alex Wallstein as Chief Executive Officer
Quasar Medical, a leading global contract manufacturer of high precision, minimally invasive medical devices, announces today that its board of directors has named Alex Wallstein as Chief Executive Officer. Ayal Amitai, CEO since July 2005, is stepping down as CEO and transitions to Executive Director of the Board and Sr. Advisor to the CEO, as well as retaining his shareholdings in Quasar. ...
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Silk Road Medical Names Rick Anderson to Board of Directors
Silk Road Medical, Inc. (Nasdaq: SILK), a company focused on reducing the risk of stroke and its devastating impact, today announced that medical device industry veteran Rick Anderson has joined its board of directors. Anderson brings over 30 years of senior executive leadership experience in the medical device industry. He is the Chairman and Managing Director of Revival Healthcare Capital, a ...
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