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Iso 13485 Articles & Analysis
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Creative Diagnostics, a leading manufacturer and supplier of antibodies, antigens and assay kits, has announced release of its new line of Human Hybrid IgM Control Monoclonal Antibodies for research applications, covering a range of diseases such as CMV, HSV, MeV, MuV, RuV, and VZV.Characteristic disease state sera are serum samples derived from individuals with specific conditions or diseases. ...
Introduction The pharmaceutical industry demands absolute precision, reliability, and safety throughout every stage of production. Whether manufacturing life-saving medicines or performing sensitive research, facilities must maintain strict control over environmental conditions. One often overlooked but essential component is gas analysis. Gases such as oxygen, nitrogen, and carbon dioxide play ...
MedSource Labs Moves the Needle in the Peripheral Safety IV Market With the announcement of ClearSafe Comfort® and TrueSafe Comfort® Blood Control IV Catheters with groundbreaking active check valve ...
CELLINK, a global leader in bioprinting technologies, is proud to announce a pioneering innovation in the field of regenerative medicine and tissue engineering with the launch of CELLINK Vivoink, the first-ever medical-grade bioink specially designed to support researchers on their clinical translational journey. CELLINK Vivoink is optimized for superior printability, mechanical stability, and ...
ByCELLINK
The U.S. Food and Drug Administration recently completed its regulatory inspection of the production site in Berlin and issued FARCO-PHARMA approval for the marketing of a sterile lubricant in disposable syringes in the United States. FARCO-PHARMA has been producing and selling the sterile catheter lubricant under the brand name GLYDO® on the U.S. market since October 2014. Medicinal ...
Portal Instruments is pleased to announce the appointment of Dr. Veena Rao, PhD, as Chief Business Officer, effective December 5th, 2022. Dr. Rao will lead the identification, evaluation, and negotiation of partnership opportunities for Portal. In addition, Dr. Rao, in close collaboration with the CEO and cross-functional team, will guide the company’s short and long-term commercial ...
VIDA Diagnostics, Inc. (“VIDA”), the leader in lung and respiratory intelligence, announced today that it has received 510(k) clearance from the Food and Drug Administration (FDA) for enhancements to its LungPrint solution, including automated deep learning-based lung and lobe segmentation algorithms. This clearance further validates the quality and clinical efficacy of the ...
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 ...
Senstech sensors can be found in a variety of applications in the medical field, such as infusion or insulin pumps, in cardiotocography or in devices for eye surgery. Other important areas of application are textile machinery, mechanical engineering, the watch industry, industrial pressure measurement technology, and applications for cars. In addition to OEM sensor solutions the company also ...
Neuros Medical, Inc., a medical device company developing an innovative, on-demand bioelectric nerve block therapy for patients with intractable post-amputation pain, announced today the completion of its QUEST Pivotal Trial 90-day primary endpoints. QUEST outcomes will remain blinded through the 12-month follow-up period, per protocol. QUEST is a 180-subject randomized, double blinded, active ...
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 ...
Cryptych P/L, Vestech’s sister company, recently passed its annual ISO 13485 audit, carried out by notified body BSi. This pass was a significant milestone and the fact that there were no non-conformances is an outstanding achievement by the whole of the Vestech team. Vestech’s experience with maintaining ISO13485 (for CE Marking and Australian compliance), as well as CFR21 for FDA ...
CathWorks, an original equipment manufacturer (OEM), and Quest International, a global service support provider to the OEMs, announced today they have signed a post-sales technical service support agreement that Quest International becomes the preferred technical service delivery partner for end-to-end service support of CathWorks’ fast-growing install-base of customers globally. CathWorks ...
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 ...
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 ...