medical device regulations News
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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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Hear from Top FDA Regulatory Experts at ACI’s 5th Annual FDA Boot Camp- Devices Edition
American Conference Institute is proud to announce that we are bringing our 5th Annual FDA Boot Camp- Devices Edition, back to Chicago on July 26-28, 2017. We specifically tailor this conference to provide regulatory professionals with in-depth coverage of current FDA law and regulations. New for this year, we have a fresh Ripped from the Headlines session, covering key developments in the FDA ...
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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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Imricor Submits for Approval to Commence VT Trial in Europe
Imricor Medical Systems, Inc. (Company or Imricor) (ASX:IMR), the global leader in real-time iCMR cardiac ablation products, is pleased to announce that the Company has submitted for approval to commence a real-time iCMR-guided ventricular tachycardia (VT) ablation clinical trial. The name of the study is “Vision-MR Ablation of VT” or VISABL-VT. VISABL-VT is a prospective, ...
By Imricor
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EDGe Surgical Receives CE Mark Certification for EDG Ortho 65mm Electronic Depth Gauge
EDGe Surgical, Inc., a company focused on developing and manufacturing smart orthopedic and spine surgical instruments, announced today that it has received a CE Certificate of Conformity from its notified body permitting CE mark of the company’s EDG Ortho 65mm single-use electronic depth gauge in the European Union market. “This is a great achievement for EDGe Surgical on several ...
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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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Is data drift an issue for medical AI models - and what can we do about it?
While medical AI has many potential benefits, there are challenges that have not been tackled yet. One of the major challenges is the limited generalizability of many AI algorithms. Applying a medical AI algorithm that is trained in hospital A may give unexpected results when applied in hospital B. Why does this happen? Certain parameters are different between hospitals. If hospital A has Siemens ...
By Segmed, Inc.
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Bluejay Diagnostics Appoints Edwin Rule as Vice President, Regulatory, Quality and Compliance
Bluejay Diagnostics, Inc. (NASDAQ: BJDX) (“Bluejay”, “the Company”) a late-stage, pre-revenue diagnostics company focused on developing cost-effective, rapid, near-patient products for triage and monitoring of disease progression, today announced that Edwin “Ed” E. Rule, has joined the Company as Vice President Regulatory, Quality and Compliance. He will report ...
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FDA Will Hold NanoDay Virtual Research Symposium on October 9
The U.S. Food and Drug Administration (FDA) Nanotechnology Task Force is celebrating NanoDay on October 9, 2020, by hosting a virtual research symposium to showcase more than a decade of progress and innovation in nanotechnology at FDA. The agenda lists the following presentations: A Decade of Progress and Innovation in Nanotechnology at U.S. FDA; Considering Whether an FDA-Regulated Product ...
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Medical certification obtained for the products of the Vaud startup
SteriLux passes the course of medical certification for the European market, thus demonstrating that its technology meets the most demanding standards in the field of health. Sterilizing heat-sensitive medical instruments without chemicals: this is the objective that the Vaud-based startup SteriLux has set itself since its creation in 2014. Its product, of sustainable design, uses ...
By SteriLux SA
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RevMedx receives CE Mark for XSTAT® injectable hemostatic devices
Revolutionary bleeding control technology will now be available in Europe and other International markets. RevMedx, Inc., a leader in innovative devices that control severe bleeding, today announced it has received CE (Conformité Européenne) Mark Certification for the XSTAT 30 and XSTAT 12 hemostatic devices in Europe. Unlike traditional wound treatments that may take several ...
By RevMedx
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Avery Biomedical Letter to Medscape Regarding Diaphragm Pacing
Please find below a letter that our attorney sent to the editors of Medscape (parent company WebMD) who have published false information about our product. Medscape Letter Regarding Avery System Avery Biomedical Devices has an outstanding track record spanning over 45 years including an outstanding safety record, long term viability with some patients pacing for more than 35 years, and ...
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Two New Uscom Devices for China
Uscom has completed the development of two new specialised cardiovascular monitors, the “USCOM O2” and the “USCOM Basic”. The development of these two new monitors creates for Uscom a three-tier range of Uscom haemodynamic monitors for sale into China. Uscom is required to obtain regulatory approval of the China National Medical Products Administration (NMPA) for the two ...
By Uscom Ltd
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YourKnee by Rejoint has received the Conformité Européene (CE) Mark
Rejoint provides the holistic approach for total knee replacement called YourKnee™ which has received the Conformité Européene (CE) Mark in January 2020. The CE marking confirms that YourKnee meets the requirements of the European Medical Devices Directive, which allows Rejoint to commercialize YourKnee and all its disposable products across the European Union and other CE ...
By Rejoint SRL
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Lynn L. Bergeson Will Speak on REACH at the CSPA International Affairs Conference
Washington D.C. -- Bergeson & Campbell, P.C. (B&C), The Acta Group, L.L.C. (Acta), and The Acta Group EU, Ltd (Acta EU) are pleased to announce that Lynn L. Bergeson will speak, Saturday, December 4, 2010, about Toxic Substances Control Act (TSCA) reform legislation and the role of the European Union's (EU) Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) ...
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RevMedx receives CE Mark for XGAUZE® self-expanding gauze.
Manufacturer of the revolutionary XSTAT technology will now have a second sterile wound dressing available in Europe and other International markets. RevMedx, Inc., a global leader in innovative devices that control severe bleeding, today announced it has received CE (Conformité Européenne) Mark Certification for the XGAUZE wound dressing in Europe. XGAUZE, a Class I sterile ...
By RevMedx
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Lynn L. Bergeson Will Speak on REACH at the CSPA International Affairs Conference
Washington D.C. -- Bergeson & Campbell, P.C. (B&C), The Acta Group, L.L.C. (Acta), and The Acta Group EU, Ltd (Acta EU) are pleased to announce that Lynn L. Bergeson will speak, Saturday, December 4, 2010, about Toxic Substances Control Act (TSCA) reform legislation and the role of the European Union's (EU) Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) ...
By Acta Group
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Lynn L. Bergeson will speak on REACH at the CSPA international affairs conference
Bergeson & Campbell, P.C. (B&C), The Acta Group, L.L.C. (Acta), and The Acta Group EU, Ltd (Acta EU) are pleased to announce that Lynn L. Bergeson will speak, Saturday, December 4, 2010, about Toxic Substances Control Act (TSCA) reform legislation and the role of the European Union's (EU) Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program at the Seventh ...
By Acta Group
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V-Wave receives second FDA breakthrough device designation: interatrial shunt for pulmonary arterial hypertension
V-Wave Ltd., a privately held medical device company developing novel implantable devices for the treatment of Heart Failure (HF), today announced that its Ventura™ Interatrial Shunt System received CE Mark and is now approved to be marketed for use in the European Union. “More than 26 million people suffer from chronic heart failure worldwide, and HF remains a leading driver of ...
By V-Wave Ltd.
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NuShores welcomes a new Quality and Regulatory medical device professional to Little Rock
Little Rock, AR – NuShores Biosciences LLC (NuShores), founded and based in Little Rock, Arkansas, announced today that Mr. Sam Monk has accepted the position of Regulatory and Quality Manager and will move to Little Rock from the Seattle area. Mr. Monk will work closely with C-level management, research scientists, manufacturing, and our Quality and Regulatory team and services providers ...
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