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(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…
(Mettler-Toledo Inc.: Columbus, OH) -- METTLER-TOLEDO, a global supplier of precision instruments and services, presents its new XP105 analytical balance, an addition to the company’s extensive line of XP balances. Offering a safe and accurate solution for quantifying the purity of sugar in a…
(SenGenuity: Hudson, NH) -- SenGenuity, the sensors division of Vectron International, announced that its TempTrackr Wireless Temperature Measurement System Kit is now capable of reading six independent, passive, wireless temperature sensors. Each sensor operates in a unique frequency band, which…
(ISO: Geneva) -- An international standard to prevent the development and marketing of products which could present health and safety risks to consumers is the goal of a new project committee (PC) from the International Organization for Standardization (ISO). The “ISO/PC 243 Consumer product…
(ANSI: New York) -- The American National Standards Institute (ANSI) has joined forces with three of the biggest names in standards to develop an unprecedented resource for medical device standards and related information.
Medical professionals can now access more than 1,300 medical device…
(FDAnews: Falls Church, VA) -- Human error causes 80 percent of drug manufacturing failures, studies indicate. Discover secrets of reducing human error, improving your products, and fending off the Food and Drug Administration (FDA) by attending the FDAnews webinar, “Reducing Human Error on…
(APQC: Houston) -- Share your knowledge management experiences at APQC’s 15th Knowledge Management Conference, April 29–30, 2010, at the Houstonian Hotel, Club & Spa in Houston, Texas. To be considered, submit your abstract by Nov. 20, using one of the methods below:
• Online form
• E-…
(MESA International: Chandler, AZ) -- MESA International presents a free webinar “Improving Performance in Difficult Times: MESA Study Shows How.” The web cast airs Wednesday, Dec. 9, at 10 p.m. in New York, and Thursday, Dec. 10, at 11 a.m. in Shanghai.
The current challenging economic…
(Canon Communications LLC: Los Angeles) -- Join 16,000 medical product development professionals from around the world at MD&M West, the world’s largest medical design and manufacturing event, Feb. 8–11, 2010.
Whether you’re planning to attend the Medical Design & Manufacturing (MD…
(FDA: College Park, MD) -- The Food and Drug Administration recently announced the publication of the new FDA Food Code, a model code and reference document that provides a scientifically sound technical and legal basis for regulating the retail and food service segment of the food industry. The…
(MasterControl: Salt Lake City) -- MasterControl, a global provider of software solutions that enable regulated companies to improve internal efficiency and reduce overall costs while accelerating time to market, recently announced that the company and i4DM, a MasterControl partner, have been…
(Ekobai Holdings Ltd.: Hong Kong) -- Ekobai.com, an online directory for certified suppliers and products has teamed up with the international organization GLOBALGAP (good agricultural practice) to produce a guide that analyzes how safety standards are changing global markets for food and…
On October 8, the federal government arrested three people in Southern California on suspicion of selling counterfeit integrated circuits (ICs) used in the manufacture of electronic devices to the U.S. Navy. The government executed search warrants at three business locations, two residences, and a…