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(PLMplus Inc.: Framingham, MA) -- PLMplus Inc. has announced the beta release of PLMplus for medical device manufacturers, an on-demand, subscription-based solution that combines quality management system (QMS) and product life-cycle management (PLM) features into a single, integrated, ready-to-…
(GxPi Ltd.: Nottingham, UK)– Regulatory compliance experts GxPi announce the availability of its leading electronic document management system (eDMS) “x-docs” as a hosted software service. x-docs hosted enables small and medium-sized organizations in the biotechnology, pharmaceutical, and health…
(ISPE: Tampa, FL) -- The International Society for Pharmaceutical Engineering (ISPE), a global nonprofit association of 24,000 pharmaceutical science and manufacturing professionals, and the U.S. Food and Drug Administration (FDA) are co-sponsoring FDA-ISPE Collaboration: Pharmaceutical Quality…
(FDA: Silver Spring, MD) -- The U.S. Food and Drug Administration (FDA) is asking commercial food transporters to follow new guidance the agency issued to reduce the chances of physical, chemical, biological, and other risks during transportation of foods while the agency reviews current…
(Sparta Systems: Holmdel, NJ) -- Sparta Systems Inc., the maker of TrackWise software and the market leader in enterprise quality and compliance management solutions, announced the release of its TrackWise Audit Execution Package. The new offering builds upon the existing robust audit capabilities…
(InterTech: Skokie, IL) -- Quality engineers seeking cost-effective ways to collect and archive test data for product life-cycle management systems and quality assurance, can now use the InterTech Development Component Tracker System, which integrates bar codes, scans, and software tracking of…
(HSM Americas Inc.: New York) -- The world’s greatest thought leaders in the field convene at the World Innovation Forum, June 8–9, at the Nokia Theatre in New York City, to provide actionable insights into the central issues at the heart of innovation today—marketing, Web 2.0, health care, social…
(Camstar: Charlotte, NC) -- Medical device companies are operating in a challenging environment of continuously innovating and launching new products while reducing product and process variability and risk and simultaneously complying with stringent Food and Drug Administration (FDA) regulations.…
(IQMS: Paso Robles, CA) -- IQMS, an innovator in the design and development of extended enterprise resource planning (ERP) software, recently announced the release of its Quality Audit Module, the most recent addition to the IQMS EnterpriseIQ suite of products. Using the new Quality Audit Module,…
(FDANews: Falls Church, VA) -- FDAnews has announced details for its 7th Annual Medical Device Quality Congress to be held June 2–4 in Bethesda, Maryland.
Changes affecting medical device firms in 2010
The year 2010 has begun with a bang. A new director at the Center for Devices and…
(PerkinElmer Inc.: Waltham, MA) -- PerkinElmer Inc., a global provider focused on the health and safety of people and the environment, recently announced that the company’s inductively coupled plasma-mass spectrometer (ICP-MS) technology can help ensure that traditional Chinese herbal medicines…
(Cognex Corp.:Natick, MA) -- Cognex Corp. recently announced In-Sight Track & Trace, an add-on software package for Cognex In-Sight vision systems. In-Sight Track & Trace delivers a ready-to-deploy data capture and verification solution designed to help pharmaceutical and medical device…
More than 90 percent of all food manufacturers have less than 200 employees. Yet, these small food manufacturers are held to the identical regulatory quality and safety standards as organizations with tens of thousands of employees. Surprisingly it is still not uncommon to find a small baked goods…
(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…