All News
(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…
(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…
(Spectral Evolution: Lawrence, MA) -- The worldwide counterfeit drug market continues to expand, both in developing and developed countries. From fake antimalarial drugs in Africa to counterfeits sold over the Internet, these drugs are detrimental in three primary ways: • Patients don’t receive the…
(Hexagon: North Kingstown, RI) -- Hexagon Metrology today officially unveiled HexagonMetrologyU, the first e-learning portal designed to engage and support the metrology industry. The interactive platform debuts over 30 online courses covering metrology fundamentals, basic and intermediate…
(CBI: Woburn, MA) -- For the past eight years, CBI’s Product Recalls Series has led the way in providing key updates and best practices for successful execution of drug, device, and diagnostic recalls corrections.
CBI’s Annual Product Recalls Summit, being held in Indianapolis on June 11–12, 2013…
(NIST: Gaithersburg, MD) -- It’s been said that the one of the most prestigious qualifications a professional can have is to say that he or she was part of the Malcolm Baldrige National Quality Award Board of Examiners. To say you served as a Baldrige examiner and were part of building American…
(NIST: Gaithersburg, MD) -- Letitia Baldrige, sister of Malcolm Baldrige, died Mon., October 29, 2012, at the age of 86. In announcing her passing, her son Malcolm Hollensteiner told the Foundation for the Malcolm Baldrige National Quality Award, Inc., that “she loved the board and took such pride…
(Banner Medical: Carol Stream, IL) -- Banner Medical executives Vince Adams, vice president of Sales, Marketing and Strategic Planning; and Bob Khin, quality assurance director; along with Peter Johns, supplier quality manager for Pioneer Surgical, will participate on a faculty panel at the…
