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(FDA: Washington) -- As part of the final phase of its transparency initiative, the U.S. Food and Drug Administration (FDA) is seeking comment from the public and other interested stakeholders on how the agency can increase transparency in its interactions with regulated industry.
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(DNV: Houston) -- A study being conducted by Michigan State University (MSU) on behalf of DNV finds that U.S. consumers are highly aware of food safety issues and they have high recognition of third-party certification as an effective signal of food safety assurance. The consumers strongly prefer…
(Sparta Systems: Holmdel, NJ) -- Sparta Systems Inc., the maker of TrackWise software and a provider of enterprise quality and compliance management solutions, has announced that a significant percentage of medical device companies currently submitting “high-volume” reports, leverage its TrackWise…
(Canon Communications: Los Angeles) -- Canon Communications announces that in 2010 it will launch three DesignMed events dedicated to the constantly evolving and highly innovative medical electronic imaging, diagnostics, and interventional device industry sectors. Electronics Design News (…
(TÜVRheinland, Newtown, CT) -- Starting March 21, all medical device manufacturers must comply with the Directive 2007/47/EC or risk being pulled from the European Community’s marketplace. TÜVRheinland and the Washington State Department of Commerce are offering a half-day seminar about the…
(Dyadem: Toronto, Ontario) -- As medical device manufacturers come under heavier scrutiny to ensure patient safety, they are increasingly looking to quality risk management (QRM) software that can identify, analyze, mitigate, and monitor quality risks throughout their organizations. Dyadem…
(ASQ: Milwaukee) -- A new survey from the American Society for Quality (ASQ) asking medical device manufacturers about industry trends and challenges shows a majority (64.7%) identify health care legislation as having a negative effect on the industry in the year ahead. Increased FDA oversight and…
(EtQ Inc.: Farmingdale, NY) -- EtQ Inc. has announced the addition of new and enhanced features in its latest release, Reliance 7.0.
Enhancements to the latest release of EtQ Reliance contribute to EtQ’s vision of providing the most robust solution in the industry. Below is a sample of just a…
(Veriteq: Richmond, BC Canada) -- “How to Avoid and Respond to Public FDA Criticisms—Form 483 Letters—for Temperature, Humidity and other Controlled Environments” is now available from Veriteq, a provider of FDA-compliant environmental monitoring, alarming, reporting, and temperature/humidity…
(Cognition Corp.: Bedford, MA) -- Cognition Corp., a worldwide leader in Web 2.0 product development software, has released Cognition Cockpit 5.6, providing medical device companies a system that captures the breadth of their product development data in a single, unified model. Information from…
(URAC: Washington) -- As part of its commitment to a comprehensive review of its standards, URAC, the nation’s leading health care accreditation and education organization, recently called for public comment on revisions to its suite of Pharmacy Quality Management Accreditation programs. URAC…
(ISO: Geneva) -- Thousands of food manufacturers worldwide stand to benefit from a newly published document in the ISO 22000 series designed to prevent and control food safety hazards.
ISO technical specification, ISO/TS 22002-1—“Prerequisite programs on food safety—Part 1: food manufacturing…
(FDA:Washington) -- The U.S. Food and Drug Administration (FDA) has issued guidance on Bayesian statistical methods in the design and analysis of medical device clinical trials that could result in less costly and more efficient patient studies.
The Bayesian statistical method applies an…
(BSI: Reston, VA) -- BSI, a notified body providing regulatory and quality management reviews for medical devices, kicks off its “Passport to Europe” program. As part of the program, BSI will be conducting a series of complimentary educational webinars for emerging, new, and small medical device…
(Camstar Systems Inc.: Charlotte, NC) -- Increasing numbers of customer complaints is typically an indicator of unresolved internal quality failures. Many companies still use fragmented applications, including paper-based systems, which lead to inconsistent processes for receiving and handling…
(Thermo Fisher Scientific Inc.: Madison, WI) -- Thermo Fisher Scientific Inc., recently unveiled an enhanced and easy-to-navigate version of its interactive UV-Visible (UV-Vis) spectrophotometer web tool. The online platform, available at www.thermo.com/selectuv, has been upgraded to include the…
(FDA: Washington) -- The U.S. Food and Drug Administration (FDA) has awarded a contract to Harvard Pilgrim Health Care Inc. to develop a pilot of the FDA’s Sentinel System, which will use automated health care data to evaluate medical product safety.
Reports filed by hospitals, health care…
(IQS: North Olmsted, OH) -- IQS announces the availability of IQS Problem Solver module that enables organizations to standardize problem solving processes with easy-to-use questioned-based reasoning software. Failure to standardize problem solving, capture reasoning, and effectively use your…
(TÜV SÜD Canada: Toronto, Canada) -- TÜV SÜD Canada, part of the global TÜV SÜD testing and certification organization, announces the acquisition of a product safety business in Toronto, Ontario, Canada. Global Advantage International is a complete product safety and regulatory compliance…
(CRC Press: New York) -- In Quality Management: Theory and Application (CRC Press, 2009), author Peter D. Mauch, Ph. D., demonstrates the necessity of quality as a sustained management activity.
Divided into five sections, the book covers staffing, motivation, control, planning, and…
(InfinityQS: Chantilly, VA) -- InfinityQS International, the leading provider of statistical process control (SPC) software, recently announced that Shearer’s Foods, the home of Shearer’s award-winning snacks, has implemented ProFicient 4 to monitor and control manufacturing processes. Shearer’s…
(Intertek: Houston) -- You’re shopping for a holiday gift, and you check the packaging to see if it’s eco friendly. How can you tell if the product really is green when it’s labeled “100% recycled,” “biodegradable,” or “environmentally friendly”?
The truth is, it can be hard to tell. As demand…
(Cybermetrics: Phoenix) -- The Food and Drug Administration (FDA) defines validation as “establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specification and quality attributes.”…
(CLSI: Wayne, PA) -- Clinical and Laboratory Standards Institute (CLSI) recently published new proposed-level guidelines.
“How to Construct and Interpret an Error Grid for Diagnostic Assays”—Proposed Guideline (EP27-P) describes what an error grid is, why it is useful, and how to go about…
(Thermo Fisher Scientific Inc.: Austin, TX) -- Thermo Fisher Scientific Inc. recently announced a new method that enables rapid and accurate identification and quantification of pesticides in rice. The QuEChERS (quick, easy, cheap, effective, rugged and safe) extraction method takes advantage of…
