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From Medical Design & Outsourcing

• Greenlight Guru to provide QMS to NIH diagnostics program
  NIH has chosen Greenlight Guru to provide quality management software for its COVID-19 rapid diagnostics program. The agency launched the Rapid Acceleration of Diagnostics (RADx) program in March 2020 to speed the development, commercialization and implementation COVID-19 testing technologies. As the only QMS provider currently available to all projects in the RADx program, Greenlight Guru… […]
• MicroCare names CFO
  MicroCare (New Britain, Conn.) has announced the appointment of John Stardellis as the company’s new chief financial officer (CFO). Stardellis joins MicroCare with more than 20 years’ experience in a variety of finance, policy and operational leadership roles. Most recently, he served as CFO at i-Health, a division of DSM Nutritional Products. “John’s track record with… […]
• Mayo Clinic helps launch two new companies for improved diagnostics
  Mayo Clinic announced that it is introducing a new technology platform to support two new companies it has launched. Rochester, Minn.–based Mayo Clinic’s Remote Diagnostics & Management Platform (RDMP) is designed to connect data with new AI algorithms and augment human decision-making within existing clinical workflows, according to a news release. Get the full story… […]
• Intertek gains FDA nod for premarket device testing
  Intertek has won accreditation under an FDA pilot program for testing laboratories, the company said this week. The accreditation authorizes Intertek’s 12 “medical centers of excellence” to perform premarket testing of devices for the U.S. market. The Accreditation Scheme for Conformity Assessment pilot program is a voluntary program developed to provide increased confidence in testing… […]
• HHS shoots down ‘flawed’ plan to let some devices skip review
  The Biden administration has nixed what it described as a “flawed” Trump-era decision to exempt certain medical devices — including infusion pump controllers and fetal monitors — from regulatory review. HHS published the original notice in the Federal Register on Jan. 15, shortly before President Joe Biden was set to take office, without speaking with… […]
• More than 50 medtech testing sites win FDA pilot accreditation
  The FDA announced today that more than 50 laboratory sites were chosen to participate in its program for streamlined regulatory reviews. In total, 53 sites made the FDA’s initial list for participation in its Accreditation Scheme for Conformity Assessment (ASCA) program, which will set out to support more streamlined regulatory reviews of medical device market… […]
• Medline Industries up for sale?
  Medline Industries is looking for a buyer in a deal that could be worth $30 billion, according to a report in the Wall Street Journal. The Journal cites “people familiar with the matter” saying that Northfield, Ill.-based Medline has hired Goldman Sachs to manage the process. The people added that the company might alternatively seek… […]
• Micro to add plant in Costa Rica
  Contract manufacturer Micro today announced plans to open a new plant in Costa Rica. The 32,000 ft² facility will significantly increase Micro’s cleanroom assembly capacity, according to the Somerset, N.J.-based company. It will be located in the Zona Franca Metro business park and is expected to open in late 2021 with operations beginning in 2022.… […]
• Survey shows solid medical device industry performance despite pandemic
  By Stewart Eisenhart, Emergo Group Medical device and IVD manufacturers report healthy performance over the course of 2020, but also faced significant operational and regulatory challenges related to the coronavirus pandemic. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not… […]
• Cardinal Health wins $58M federal PPE contract
  Cardinal Health (NYSE: CAH) today said it has won a $57.8 million contract from the U.S. Dept. of Health and Human Services to support the Strategic National Stockpile. The Dublin, Ohio-based company received the contract, which includes options that if exercised by the HHS could reach $91.6 million, to store and distribute 80,000 pallets of… […]
• Qosina adds single-use bioprocessing devices
  Qosina this week launched its product line for the single-use bioprocess industry. The new product line includes tube-to-tube bard connectors, luer fittings, check valves, tubing pinch clamps, tubing, steam thru connectors and more. Get the full story on our sister site, Medical Tubing + Extrusion. The post Qosina adds single-use bioprocessing devices appeared first on […]