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(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…
(Q1 Productions: Chicago, IL) -- For the second consecutive year, Q1 Productions will be hosting the Medical Device Product Development and Management Conference, offering attendees an opportunity to obtain the up-to-date and valuable industry information and network with fellow healthcare…
(Chicago, IL) -- Q1 Productions will be hosting the inaugural Pharmaceutical Supplier Quality Assurance Conference July 21-22, 2014, in Arlington, Virginia, fulfilling the demand for a tailor-made meeting for supplier quality assurance professionals within the pharmaceutical industry.…
(RAND: Santa Monica, CA) -- After a decade of experimentation with reforms that give health providers financial incentives to improve performance, relatively little is known about how to best execute such strategies or judge their success, according to a new report from RAND Corp.
A comprehensive…
Commerce Secretary Penny Pritzker has announced that three U.S. organizations will receive the 2013 Malcolm Baldrige National Quality Award, the nation's highest presidential honor for performance excellence through innovation, improvement, and visionary leadership. All of this year's winners are…
(Quality Digest: Chico, CA) -- Are you passionate about quality? Do you want to lead tens of thousands of like-minded quality individuals? Then this job is for you.
The American Society for Quality (ASQ) is looking for a new CEO. According the job posting on ASQ's site:
"The next CEO will lead and…
(NIST: Gaithersburg, MD) -- As most of you have likely heard, the federal government is shutting down due to a lapse in funding. While this will undoubtedly create hardship for many who work for and/or rely on services from the government, I am happy to inform you that the Baldrige Program will…