All News
(A2LA: Frederick, Maryland) -- The American Association for Laboratory Accreditation began adding medical laboratories to its accreditation offerings on June 1, 2007. “We see strong demand for an internationally recognized accreditation program in the medical laboratory industry,” says…
(DHHS: Washington) -- Health and Human Services Secretary Mike Leavitt recently announced that the United States will participate in an international effort to encourage more rapid development and worldwide adoption of standard clinical terminology for electronic health records. The…
(NCQA: Washington) -- Women are significantly less likely than men to have their LDL cholesterol controlled to recommended levels, according to a new study by the National Committee for Quality Assurance. The study, published in the May/June edition of Women’s Health Issues,…
(Natus: San Carlos, California) -- Natus Medical Inc. recently announced that it was awarded a 2007 Medical Design Excellence Award for its Olympic Cool-Cap head-cooling product for newborn brain injury. The award will be presented to Natus at a ceremony to be held June 13, 2007, in New York City.…
(FDA: Washington) -- U.S. Food and Drug Administration investigators and U.S. marshals recently seized all implantable medical devices from Shelhigh Inc., Union, New Jersey, after finding significant deficiencies in the company’s manufacturing processes. The deficiencies may compromise…
(Standard Register: Dayton, Ohio) -- For the third consecutive year, Standard Register was named a 2006 Platinum Supplier by MedAssets Supply Chain Systems, a St. Louis-based group purchasing and supply chain services company. The award was recently presented at the 2007 MedAssets…
(FDA: Washington) -- The U.S. Food and Drug Administration announced the entry of a Consent Decree of Permanent Injunction against PharmaFab Inc., its subsidiary, PFab LP, and two company officials, Mark Tengler, PharmaFab’s president, and Russ McMahen, PFab’s vice president of…
(Food and Drug Administration: Rockville, Maryland) The U.S. Food and Drug Administration has unveiled a new Web page that will keep the public informed about the status of post-approval patient studies for certain recently approved medical devices. “FDA is committed to improving its medical…
(TAGSYS: Cambridge, Massachusetts) -- TAGSYS, a provider of item-level radio frequency identification (RFID) infrastructure, has announced its unprecedented RFID “Six Sigma Performance Program” for pharmaceutical manufacturers. Six Sigma is a quality-of-service performance guarantee of…
(ITI Global: Milford, Ohio) – Hitachi Medical Corp. has received from its parent organization, Hitachi Ltd., the 2006 Innovation Award recognizing the most innovative product and process developed for the year. Hitachi Medical received the award for the multimodality console product…
(Angiotech Pharmaceuticals Inc., Vancouver) -- Angiotech Pharmaceuticals Inc., global specialty pharmaceutical and medical device company, recently announced the appointment of Victor Diaz as senior vice president, global manufacturing and supply chain management.“With his significant…
(Pilgrim Software, Tampa, Florida) -- Pilgrim Software, a provider of enterprise compliance and quality management software solutions, has been named 2007 North American Enterprise Compliance & Quality Management (ECQM) Company of the Year within the life sciences industry by Frost…
(Sparta Systems Inc.; Holmdel, New Jersey) Sparta Systems Inc., the maker of TrackWise, and an enterprise quality and compliance process management software provider, has released the Beta version of the TrackWise eMDR Submission Manager software. The add-on software enables medical…
Five pharmaceutical manufacturing facilities scattered around the globe recently received Facility of the Year awards for significantly advancing the industry’s efforts to produce higher-quality medicines at lower costs. The winners are: Cook Pharmica—Facility of the Year for Facility…
(Underwriters Laboratories Inc.; Northbrook, Illinois) -- Underwriters Laboratories Inc., a world leader in product safety testing, and certification and management system registrations, recently unveiled a service for the medical device industry that streamlines the regulatory…
Blue Mountain Quality Resources Inc. and eCalibration.com have collaborated on a spring training schedule. The courses are designed to provide unique and leading-edge training for professionals working in regulated life sciences industries. The courses include: • Facilities and Equipment…
Solectron Corp. recently created an alliance for medical device outsourcing companies. The Solectron Medical Alliance Program (S-MAP) includes ATEK Medical, Circle Medical, Proven Process Medical Devices Inc. and SRI Product Development, as well as Solectron. The alliance creates one of…
Hitachi Medical Corp. (HMC) recently received the 2006 Innovation Award in recognition of its development of new products and processes. Almost 60 North American imaging and 140 Japanese hospitals helped define the critical product capabilities that Hitachi Medical and International…
Three medical device manufacturers—two in Mexico and one in the United States— recently received Shingo Prizes. Baxter Healthcare Corp.’s North Cove Plant in Marion, North Carolina; Baxter’s Cuernavaca Plant in Morelos, Mexico; and Cordis Corp. of Juarez, Mexico, received the awards,…
QUMAS recently made its QUMAS R&D software suite available to biotechnology and pharmaceutical companies. QUMAS provides regulatory affairs and quality management solutions, and the new research and development suite is the first of a series for the life sciences that will focus on…
Agile Software Corp., a provider of product lifecycle management solutions, recently reported that CooperVision, a fast-growing manufacturer of contact lenses, has installed Agile Product Quality Management as its global quality solution earlier than expected.“It was the easiest and…
The Food and Drug Administration recently proposed recommendations to Congress that would broaden and upgrade the agency’s drug safety plan, increase resources for television advertising review and improve drug development processes. The recommendations are part of the reauthorization…
A Food and Drug Administration senior scientist will be the next chairman for the agency’s Global Harmonization Task Force, which was established as an international effort to improve the quality of medical devices and regulatory systems. Dr. Larry Kessler is director of the office of…
Pharmatech Associates Inc. has established a Regulatory Compliance Group that’s designed to help the consultancy’s clients ensure long-term drug development compliance with Food and Drug Administration regulations. The RCG’s team members include former FDA employees who have extensive…
Solectron Corp. will host an upcoming seminar on the effect of the restriction of hazardous substances (RoHS) directive on American medical device makers. RoHS is a European requirement that prohibits the marketing of electronic and electrical equipment that contains hazardous substances—…
