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(Greenlight Guru: Indianapolis, IN)--Greenlight Guru, pioneer of the Medtech Lifecycle Excellence Platform, has acquired SMART-TRIAL, maker of the first and only electronic data capture (EDC) platform designed for medical devices and diagnostics. SMART-TRIAL offers a comprehensive data collection…
(Exemplar Global: Milwaukee) -- Just like aviation flight simulators, the Audit Simulator provides opportunities to audit without risk. Using the simulator, trainee auditors have access to standards and/or checklists, evaluate evidence and comments, then make decisions and give their review on the…
First published Aug. 6, 2021, on MIT News.
Engineers at MIT and Harvard University have designed a small tabletop device that can detect SARS-CoV-2 from a saliva sample in about an hour. In a new study, they showed that the diagnostic is just as accurate as the PCR tests now used.
The device can…
(NIST: Boulder, CO)— The U.S. Department of Commerce’s National Institute of Standards and Technology (NIST) has launched a new prize competition to advance the use of unmanned aircraft systems (UAS) in first responder search and rescue operations.
Unmanned aircraft such as drones could be…
(Greenlight Guru: Indianapolis) -- Greenlight Guru, the leading medical device quality management software (MDQMS) platform, announces the launch of Greenlight Guru Academy, a learning resource providing free online training for medical device quality, regulatory, and product development…
(Thermo Fisher Scientific: Basingstoke, UK) -- A quick and easy culture-based method for the enrichment, detection, and confirmation of Salmonella species has been validated for the broadest range of food, animal feed, and environmental samples, and is ready to slot into standard laboratory…
(University of Rochester: Rochester, NY) -- Researchers in Rochester are developing an optical chip on a disposable card that can detect exposure to multiple viruses within a minute—including the coronavirus that causes Covid-19—from a single drop of blood.
Led by University of Rochester Medical…
(Brooks Life Sciences: Chelmsford MA) -- Brooks Life Sciences, a division of Brooks Automation, announces the immediate availability of BioStore IIIv, an automated next-generation alternative to manual -80° mechanical freezers. BioStore IIIv provides the documentation rigor when managing high-value…
(ISO: Geneva) -- Clinical investigation of medical devices is naturally highly regulated, with numerous national and regional rules and requirements that must be adhered to by manufacturers and investigators, as well as other parties involved in clinical trials.
ISO 14155: “Clinical investigation…
(MIT News: Cambridge, MA) -- Many MIT students, like their beaver mascot, are well-known for engineering skills, industrious habits, and for creating some amazing things late into the night. So, an ambitious project to build a 1:1 scale replica of MIT in Minecraft may come as no surprise. “As MIT…
(ETQ: Boston) -- ETQ, a leading provider of quality management solutions, released findings from a first-of-its-kind research study–“The State of Quality Management: 2020.” According to the survey, companies are investing more in quality as a strategic business growth initiative that brings a…
(Greenlight Guru: Indianapolis) -- Greenlight Guru, creator of the only quality management software designed specifically for the medical device industry, announces new software platform updates to align with the recently updated ISO 14971:2019 standard, as well as further enhancements to the change…
(Renishaw: Wotton-under-Edge, Gloucestershire) -- The youngest patient in the world to receive deep brain stimulation has undergone surgery at Evelina London Children’s Hospital in London. The aim of the procedure was to help the patient, Viktoria Kaftanikaite, who was just two years old, to manage…
(Vireo Health: Minneapolis) -- As America’s leading physician-led cannabis company, Vireo Health has long been dedicated to providing high-quality cannabis products and unrivaled patient care. Kyle Kingsley,a board-certified emergency medicine physician, founded Vireo Health after serving on the…
(ISO: Geneva) -- While some countries have made great progress toward universal health coverage, half the world’s population are still unable to obtain the health services they need. The International Organization for Standardization (ISO) and the World Health Organization (WHO) are working…
(FDA: Silver Spring, MD) -- The U.S. Food and Drug Administration has published an Electronic User Guide for its Accredited Third-Party Certification Program Portal.
In this voluntary program, established by the FDA Food Safety Modernization Act, the agency recognizes “accreditation bodies” that…
(Greenlight Guru: Indianapolis) -- Greenlight Guru, the only quality management software platform designed specifically for medical device companies, announces a new integration with Jira, creating an adaptive system for managing product development and post-market quality for devices with software…
(ANSI: Washington, D.C.) -- The American National Standards Institute (ANSI), a recognized accreditation body under the U.S. Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA), encourages relevant stakeholders to utilize the FDA’s Voluntary Qualified Importer Program (VQIP)…
(CRC Press: Boca Raton, FL) -- In the book, Health Care in the Next Curve (CRC Press, 2018), author John Abendshien takes an objective and sometimes scathing look at the current industry structure: a silo-driven culture and entrenchment that is driven by self-interest, as well as the complicity of…
(CBI UBM: Burlington, MA) -- IVT Network, the trusted source for life sciences validation and compliance knowledge, is featuring its flagship event, the 24th Annual Validation Week Oct. 22–24, 2018, in San Diego. Melanie Demakis, IVT’s senior conference producer, recently worked with Connie Hetzler…
(ISO: Geneva) -- The Food and Drug Administration (FDA), an agency within the U.S. Department of Health and Human Services, announced its intention to use ISO 13485 as the basis for its quality system legislation.
The International Organization for Standardization’s (ISO) international standard, …
(MIT News: Cambridge, MA) -- Using a machine-learning system known as a deep neural network, MIT researchers have created the first model that can replicate human performance on auditory tasks such as identifying a musical genre.
This model, which consists of many layers of information-processing…
(Sparta Systems: Hamilton, NJ) -- A recent survey sponsored by Sparta Systems and conducted by Pharmaceutical Technology, found that while compliance remains the top objective in 2018 among 73 percent of pharmaceutical executives, performance-oriented objectives were nearly as critical for the…
(IVT Network: Burlington, MA) -- The Institute of Validation Technology (IVT) Network, a part of UBM plc, announces the launch of its hands-on, interactive “Quality Risk Management and Change Control” training, taking place Feb. 27—March 1, 2018, in San Diego.
The event is focused on providing…
(marcus evans: London) --The Information Management and Data Quality for Pharma Sector Conference, organized by the marcus evans Group, will focus on gathering corporate professionals from regulatory operations, regulatory affairs, master data management, regulatory information systems, and other…