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(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…
(AssurX: Morgan Hill, CA) -- AssurX, Inc., a leading enterprise quality management, risk, and regulatory compliance solution provider, has released the latest update to its AssurX audit management software.
Key benefits to the organization The AssurX software update keeps all stages of the audit…
(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…
FDA will be taking applications starting Sept 1, 2015, looking for makers of class I and suitable class II medical devices to participate in a pilot program to file malfunction reports in summary form quarterly. Get on the stick, though, if you are interested: there are only nine slots.
Under FDA…
(PQ Systems: Dayton, OH) -- PQ Systems, a Dayton-area quality management software developer, announces new ownership of the company as of June 1, 2015.
Beth Savage, PQ Systems operations manager since 2007, has acquired ownership of the company’s shares formerly held by the family of Michael J.…
(FDA: Silver Spring, MD) -- The U.S. Food and Drug Administration (FDA) has taken important steps to help manufacturers develop biologic products called biosimilars. Biosimilars are highly similar to, and have no clinically meaningful differences from, an already approved biological product.…
(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…
(Q1 Productions: Chicago) -- The Pharmaceutical Supply Chain Management Conference is back with the biggest names from all corners of the industry presenting valuable information on the most time-sensitive topics. This year, more than a dozen experts from small, midsize, and large companies will…
(Q1 Productions: Chicago) -- Across the medical device industry, from corporations preparing to launch a first product, to those with thousands of products being manufactured across disparate global sites, executives are constantly working to update, maintain and evolve quality systems to ensure…
(Metronor: Oslo, Norway) Metronor—a leading supplier of industrial and military geometry measurement systems—has won the first multi-system contract for its new line of precision guidance systems for surgical procedures.
Developed from mature Metronor core technology, the new product line offers…