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(BioCision: San Rafael, CA) -- BioCision LLC, a life science research and development company that standardizes basic laboratory processes, has announced the formation of MedCision Inc., an independent company focused on automation of pre-clinical and clinical processes.
“The formation of…
(Control Micro Systems: Orlando, FL) -– Control Micro Systems (CMS) has developed turnkey laser marking and cutting systems for industry-leading clients in the medical sectors.
Manufacturers of endoscopic guidewire devices frequently are required to mark brand and model information as well as…
A new imaging technique developed by scientists at MIT, Harvard University, and Massachusetts General Hospital (MGH) aims to illuminate cellular structures in deep tissue and other dense and opaque materials. Their method uses tiny particles embedded in the material, that give off laser light.…
(FDA: Washington, D.C.) -- The U.S. Food and Drug Administration (FDA) has awarded a total of $21.8 million to support 42 states to help implement the FDA Food Safety Modernization Act (FSMA) produce-safety rule. The rule, which the FDA finalized in November 2015, establishes science-based minimum…
(Productivity Press: Boca Raton, FL)) -- Shingo award winner and bestselling author Tom Zidel’s newest book, Rethinking Lean in Healthcare (Productivity Press, 2016) deals with hospitals’ struggle to secure and maintain financial stability. In story form, Zidel tells how the leadership team of a…
(marcus evans: London) -- Pharmaceutical quality systems have shifted in recent years from a traditional model to a more global, dynamic, and risk-based approach, enhanced especially by regulatory authorities and economic environment. marcus evans is organizing the conference, “Quality Risk…
(Productivity Press: New York) -- You likely don’t need any more tools, programs, or workshops to improve your hospital. What you need is a simple and consistent approach to manage problem-solving. Filling this need, Lean Daily Management for Healthcare: A Strategic Guide to Implementing Lean for…
(FDA: Washington, DC) -- During the last few months, we’ve shared what the FDA is doing to improve the review of combination products, including establishing the Combination Product Council and identifying necessary process improvements through lean mapping of the combination product review…
(CRC Press: Boca Raton, FL) -- In a cool and readable style, Andy & Me and the Hospital: Further Adventures on the Lean Journey follows Tom Pappas’s relationship with Andy Saito, a reclusive retired Toyota guru. Tom and Andy are pulled into a major New York City hospital in crisis. Can they…
(ISO: Geneva) -- Exposure to ionizing radiation is a potential risk in many situations, and the International Organization for Standardization (ISO) has a score of standards that help ensure exposure levels are kept within safe limits. Now, two new standards have been published that focus on the…
(NIST: Gaitherburg, MD) -- Medical devices such as the infusion pumps that deliver medication intravenously were once standalone instruments that interacted only with the patient. Today, they have operating systems and communications hardware that allow them to connect to other devices and…
(MOCON: Minneapolis) -- Cleanroom operators will now be able to detect the presence of extremely low levels of microbial cells on surfaces much faster than with traditional solutions. This cleanroom testing capability is a result of a global marketing agreement between MOCON Inc. and Particle…
Taking a cue from Toyota, the newly published book Lean Culture Change Using a Daily Management System (Align Kaizen, 2015) by lean transformation coach and author Steven Leuschel applies decades of organizational transformation knowledge deeply rooted in the Toyota Production System and in Toyota…
(ANSI) -- The Food and Drug Administration (FDA) is requesting feedback on the use of the term “natural” in food labeling. The action is a response to consumers who have requested that the administration explore the use of this term on food labels, considering the changing landscape of food…
(Gartner: Stamford, CT) -- Gartner Inc. has released its seventh annual Healthcare Supply Chain Top 25 ranking. The 2015 ranking recognizes companies across the healthcare value chain that demonstrate leadership in improving patient care and lowering costs.
"Alignment to patient outcomes, company…
(ISO: Geneva) -- A standard for quality management systems specific to the medical devices industry is under review and has just moved a step closer to completion.
We take it for granted that devices used in hospitals or medical centers are of high quality and up to scratch, but for manufacturers…
(FDA: Silver Spring, MD) -- openFDA is releasing information on medical devices that could spur innovation and advance scientific research.
openFDA’s application program interface expands on the previous openFDA resources concerning medical device-related adverse events and recalls by…
(NIH: Bethesda, MD) -- Poor quality medicines are a real and urgent threat that could undermine decades of successful efforts to combat HIV/AIDS, malaria, and tuberculosis, according to the editors of a collection of journal articles published April 20, 2015.
Scientists report up to 41 percent…
(AssurX: Morgan Hill, CA) -- A new FDA guidance issued by the Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) offers some helpful detail for device firms uncertain if post-approval studies can replace premarket studies at the time of…
(Quality Digest -- Chico, CA) Quality Digest, for more than 30 years the leading source for quality news and resources, is now available on mobile devices. Check out our website on your smartphone or tablet for exclusive content, in-depth articles and columns, industry news, webinars, and more.…
(Frost & Sullivan: London) -- Increasing procedure volumes have been fuelling the adoption of custom procedure trays and packs (CPTP) in Western and Eastern Europe. In part, the expanding aging population, which is more likely to develop chronic wounds as they have more medical issues…
(InfinityQS: Fairfax, VA) -- InfinityQS International Inc., the global authority on real-time quality and manufacturing intelligence, recommends five ways pharmaceutical and medical device manufacturers can use enterprise quality systems, manufacturing intelligence platforms, and automated device…
(Roland DG: Irvine, CA) -- Roland DG Corp., parent company of Roland DGA, announced that its medical instrument traceability and maintenance support system project, run in conjunction with Japan’s Hamamatsu University School of Medicine, has been selected by the Ministry of Economy, Trade and…
(LNS Research: Cambridge, MA) -- LNS Research, a technology research and advisory firm focusing on the industrial value chain, has released its Environment, Health & Safety (EHS) Research Library. Comprising research-based best practices, benchmark data, and thought leadership publications,…
Michael J. Cleary, Ph.D., founder and president of PQ Systems Inc. and a professor emeritus at Wright State University in Dayton, Ohio, died suddenly on September 10, 2014.
Cleary was born June 3, 1939, in Dumont, New Jersey. He was a graduate of Norwich University and was commissioned as a second…